Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Carefusion 2200 Inc Jun-29-2012 AirLife Isothermal Breathing Circuit; Infant Respiratory Circuit; Non-Heated – AirLife Isothermal Breathing Circuit; Infant Respiratory Circuit; Non-Heated; an Rx device for single patient use; CareFusion; 22745 Savi Ranch Parkway; Yorba Linda; CA 92887 USA; Made in MexicoRespiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. The Y adapter within the breathing circuit may spontaneously crack; causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Carefusion 2200 Inc Jun-29-2012 AirLife Isothermal Breathing Circuit; Infant Respiratory Circuit; Heated – AirLife Isothermal Breathing Circuit; Infant Respiratory Circuit; Heated; an Rx device for single patient use; CareFusion; 22745 Savi Ranch Parkway; Yorba Linda; CA 92887 USA; Made in MexicoRespiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. The Y adapter within the breathing circuit may spontaneously crack; causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Carefusion 2200 Inc Jun-29-2012 AirLife Isothermal Breathing Circuit Accessory – Infant Patient Y Connector – AirLife Isothermal Breathing Circuit Accessory – Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion; 22745 Savi Ranch Parkway; Yorba Linda; CA 92887 USA; Made in MexicoRespiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. The Y adapter within the breathing circuit may spontaneously crack; causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Arrow International Inc Jun-26-2012 Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter – Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) CatheterProduct Usage:The multiple-lumen catheter permits venous access to central circulation. Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.
Fresenius Medical Care Holdings; Inc. Jun-25-2012 Fresenius NaturaLyte Liquid Acid Concentrate – Fresenius NaturaLyte Liquid Acid ConcentrateProduct Codes: 08-0231-4; 08-1001-0; 08-1201-8; 08-1231-3; 08-1251-1; 08-1301-4; 08-2201-5; 08-2231-2; 08-2251-0; 08-2301-3;08-2351-8;08-3201-4;08-3231-1;08-3251-9;08-3301-2;08-4123-1; 08-4223-7; 08-4225-1′ 08-4230-2; 08-4231-0; 08-4323-5; 08-4325-1; 13-1251-1; 13-2201-5; 13-2231-2; 13-2251-0; 13-3231-1;13-3251-9; 13-4123-1′ 13-4220-1; 13-4225-1 ‘ 13-4325-1.For the treatment of acute and chronic renal failure during hemodialysis procedure. Risk of Alkalosis with acetate containing dialysis acidconcentrates
Fresenius Medical Care Holdings; Inc. Jun-25-2012 Fresenius GranuFlo (powder) Acid Concentrate – Fresenius GranuFlo (powder) Acid ConcentrateProduct Codes:OFD1201-3B; OFD1251-3B; OFD2123-3B; OFD2201-3B; OFD2220-3B; OFD2223-3B;OFD2225-3B; OFD2231-3B; OFD2251-3B; OFD2301-3B; OFD2323-3B; OFD2325-3B; OFD3201-3B; OFD3231-3B; OFD3251-3B; OFD3301-3B.For the treatment of acute and chronic renal failure during hemodialysis procedure. Risk of Alkalosis with acetate containing dialysis acidconcentrates
Nidek Medical Products Inc Jun-19-2012 NIDEK Medical NUVO LITE MODEL 925 OCSI; 3LPM 230V – 60Hz – 280W – NIDEK Medical NUVO LITE MODEL 925 OCSI; 3LPM 230V – 60Hz – 280W.Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Nidek Medical Products Inc Jun-19-2012 NIDEK Medical MARK5 NUVO / M5C5; 115 V ~60Hz – 410 W – NIDEK Medical MARK5 NUVO / M5C5; 115 V ~60Hz – 410 W.Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Nidek Medical Products Inc Jun-19-2012 NIDEK Medical NUVO LITE MODEL 520 STD; 115V – 60Hz – 330W – NIDEK Medical NUVO LITE MODEL 520 STD; 115V – 60Hz – 330W.Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Nidek Medical Products Inc Jun-19-2012 NIDEK Medical NUVO LITE MODEL 525 OCSI; 115V – 60Hz – 330W – NIDEK Medical NUVO LITE MODEL 525 OCSI; 115V -60Hz – 330W.Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Nidek Medical Products Inc Jun-19-2012 NIDEK Medical MARK5 NUVO 8 /OCSI; 230 V~50/60Hz – 420 W – NIDEK Medical MARK5 NUVO 8 /OCSI; 230 V~50/60Hz – 420 W.Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Nidek Medical Products Inc Jun-19-2012 NIDEK Medical MARK5 NUVO 8 STD; 115 V~60Hz – 500W – NIDEK Medical MARK5 NUVO 8 STD; 115 V~60Hz – 500W.Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Nidek Medical Products Inc Jun-19-2012 NIDEK Medical M5C5/ MARK5 NUVO/OCSI; 230 V~50/60 Hz -420 W – NIDEK Medical M5C5/ MARK5 NUVO/OCSI; 230 V~50/60 Hz -420 W.Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Nidek Medical Products Inc Jun-19-2012 NIDEK Medical M5C5/ MARK5 NUVO/STD; 230 V~50/60 Hz -420 W – NIDEK Medical M5C5/ MARK5 NUVO/STD; 230 V~50/60 Hz – 420 W.Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Nidek Medical Products Inc Jun-19-2012 NIDEK Medical NUVO LITE MODEL 925 OCSI; 230V – 50Hz – 300W – NIDEK Medical NUVO LITE MODEL 925 OCSI; 230V – 50Hz – 300W.Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
GE Healthcare; LLC Jun-17-2012 Aestiva/5 7900 SmartVent" – GE Healthcare; Aestiva/5 7900 SmartVent"; anesthesia machine; GE Healthcare P.O. Box 7550 Madison; WI 53707-7550.This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based; electronically controlled; pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen; airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses; fresh gas contribution and small leakage in the breathing absorber; bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device; include Volume Mode; Pressure Control Mode; Synchronous Intermittent Mandatory Ventilation (optional); Pressure Support with Apnea Backup Ventilation (optional). This device is to be used only by trained and qualified medical professionals GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m
Sigma Jun-13-2012 Spectrum – Sigma Spectrum VOLUMETRIC INFUSION PUMP; with or without Master Drug Library; Part Number 35700 — Common/Classification Name: Infusion Pump — Class 2 medical device — SIGMA LLC; Medina; NY 14103 Product Usage:The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood; blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention; through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library; the intended use is to reduce user errors associated with drug selection; drug dose rates; drug dose concentrations; and patient identification associated with the prescribed drug. Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow; which could result in over-infusion. Sigma’s evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initiall
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Genesys Orthopedic Systems; LLC Jun-01-2012 Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter – Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System.The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant. The inserters have the potential to break.
Ortho-Clinical Diagnostics Jun-01-2012 VITROS 5600 Integrated System – VITROS 5600 Integrated System Software Version 1.6 & BelowProduct Usage:For use in the in vitro quantitative; semi-quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Chemistry Products Slides; VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a CurveTip position.
Siemens Healthcare Diagnostics Jun-02-2012 IMMULITE 2000 – IMMULITE 2000 — Insulin — Catalog Number: L2KIN2 (200 test); L2KIN6 (600 tests) — Test Code: INS; Color: Orange — Product Usage:For in vitro diagnostic use with IMMULITE and IMMULITE 1000 Systems Analyzers — for the quantitative measurement of insulin in serum or heparinized plasma; for the management of diabetes. Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.
Siemens Healthcare Diagnostics Jun-02-2012 IMMULITE – IMMULITE — Insulin — Catalog Number: LKIN1 (100 test); LKIN5 (500 tests) — Test Code: INS; Color: Orange Product Usage:For in vitro diagnostic use with IMMULITE and IMMULITE 1000 Systems Analyzers — for the quantitative measurement of insulin in serum or heparinized plasma; for the management of diabetes. Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.
Invacare Corporation Jun-05-2012 Knee Walker – Knee walker; one unit per box. Manufacturer Kenstone Metal (Kunshan) Co.; LTD. The intended use is to provide additional mobility to individuals who have difficulty walking. Adverse event data prompted testing of device; which revealed that the rod supporting the knee pad was not made to specifications. Upon placing a load on the knee pad; the rod may break or bend causing the walker to collapse. As a result; the user may fall.
Spacelabs Healthcare; Llc Jun-05-2012 Model 91393; Xprezzon Bedside Monitor – Product is the Spacelabs Medical Xprezzon Bedside Monitor; Model 91393.The Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. It can also function as a generic display or computer terminal. It is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a hospital environment. It passively displays data generated by Spacelabs parameter modules; Flexport interfaces; and other Spacelabs SDLC based products as waveform and numeric displays; trends and alarms. Key monitored parameters available on this model; when employing the Spacelabs Command Module; consist of ECG; respiration; invasive and noninvasive blood pressure; SpO2; temperature and cardiac output. The screw used to connect the external power supply to the Spacelabs Medical Xprezzon Bedside Monitor; Model 91393; may damage an internal capacitor. The damage may result in an inability of the monitor to power on; power off; or involuntarily shut down.
Stryker Spine Jun-05-2012 Xia 3 Anti-Torque Key – Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. Product Usage: :Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: The Anti-Torque Key allows the Torque Wrench to align with the tightening axis and maximizing the torque needed to lock the implant assembly during final tightening of the spinal construct. Stryker received four reports regarding a handle which separates at the point where it is welded to the shaft on the Xia 3 Anti-Torque Key during surgery.
Excelsior Medical Corp Jun-05-2012 Heparin Lock Flush – Heparin Lock Flush Solution 100 Unit/mL; USP3 ml; 5mL; 6 ml fill in a 10mL Flush Syringe ZRExcelsior Medical Neptune; NJ 07753(800) 487-4276Made in USANDC 63807060055.Used to maintain patency of vascular access devices designed for intermittent infusion therapy. Export product for sale in Colombia are used for locking hemodialysis catheters; for heparinization of extracorporeal systems; in hemodialysis; and for peritoneal dialysis. Some lots of Heparin Lock Flush; USP Syringes (3 mL fill in 10 mL syringe; 4 mL fill in 10 mL syringe; 5 mL fill in 10 mL syringe); failed Anti-Factor IIa assay for potency.
Advanced Sterilization Products Jun-06-2012 Sterrad Cyclesure 24 Biological Indicator – Sterrad Cyclesure 24 Biological Indicator; P/N: 14324The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. The recall was initiated by Advanced Sterilization Products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture of a specific lot range of Sterrad Cyclesure 24 Biological Indicator.
Smith & Nephew Inc Jun-06-2012 6.0 MM DIAMETER 50 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V – 6.0 MM DIAMETER 50 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V; REF 71932962; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) STERILE DRILL – 4.8 MM X 1.8 MM DRILL FOR HA COATED HALF PINS; CANNULATED; REF 71070845; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 2.0 MM X 191 MM DRILL – 2.0 MM X 191 MM DRILL; REF 71173802; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 2.7 MM X 191 MM DRILL – 2.7 MM X 191 MM DRILL; REF 71173804; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 3.5 MM X 191 MM DRILL – 3.5 MM X 191 MM DRILL; REF 71173806; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 .2 MM LONG GRADUATED BRAD POINT DRILL – 3.2 MM LONG GRADUATED BRAD POINT DRILL; REF 71751149; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 3.2 MM LONG GRADUATED BRAD POINT DRILL – 3.2 MM LONG GRADUATED BRAD POINT DRILL; REF 71780105; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 3.2 MM IMHS(R) CP SHORT BRAD POINT DRILL – 3.2 MM IMHS(R) CP SHORT BRAD POINT DRILL; REF 71687001; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 2.0 MM DRILL BIT – 2.0 MM DRILL BIT; REF 71173501; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 2.7 MM DRILL BIT – 2.7 MM DRILL BIT; REF 71173503; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 3.2 MM TROCAR – 3.2 MM TROCAR; REF 71751136; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6.5 MM CANELLOUS TAP W/ QUICK CONNECT – 6.5 MM CANELLOUS TAP W/ QUICK CONNECT; REF 71173509; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 PERI-LOC(R) TARGETER 2.7 MM PF PIN 18 MM; SST – PERI-LOC(R) TARGETER 2.7 MM PF PIN 18 MM; SST; REF 71173438; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 PERI-LOC(R) TARGETER 2.7 MM PF PIN 40 MM; SST – PERI-LOC(R) TARGETER 2.7 MM PF PIN 40 MM; SST; REF 71173406; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 PELVIS PIN – PELVIS PIN; REF 71366302; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 ACETABULAR PIN – ACETABULAR PIN; REF 71366301; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 SMALL JOYSTICK THREADED PIN – SMALL JOYSTICK THREADED PIN; REF 71173396; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 LARGE JOYSTICK THREADED PIN – LARGE JOYSTICK THREADED PIN; REF 71173339; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 4.5 MM X 10 MM X 150 MM HA COATED HALF PIN SST – 4.5 MM X 10 MM X 150 MM HA COATED HALF PIN SST; REF 71070823; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 4.5 MM X 20 MM X 150 MM HA COATED HALF PIN SST – 4.5 MM X 20 MM X 150 MM HA COATED HALF PIN SST; REF 71070824; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 4.5 MM X 30 MM X 150 MM HA COATED HALF PIN SST – 4.5 MM X 30 MM X 150 MM HA COATED HALF PIN SST; REF 71070825; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST – 4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST; REF 71070826; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 4.5 MM X 50 MM X 150 MM HA COATED HALF PIN SST – 4.5 MM X 50 MM X 150 MM HA COATED HALF PIN SST; REF 71070827; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 15 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 15 MM X 150 MM HA COATED HALF PIN SST; REF 71070828; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 20 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 20 MM X 150 MM HA COATED HALF PIN SST; REF 71070800; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 25 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 25 MM X 150 MM HA COATED HALF PIN SST; REF 71070802; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 30 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 30 MM X 150 MM HA COATED HALF PIN SST; REF 71070804; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 35 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 35 MM X 150 MM HA COATED HALF PIN SST; REF 71070806; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 40 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 40 MM X 150 MM HA COATED HALF PIN SST; REF 71070808; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 45 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 45 MM X 150 MM HA COATED HALF PIN SST; REF 71070835; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 50 MM X 150 MM HA COATED HALF PIN; 1.6 MM CANNULATED; SST – 6 MM X 50 MM X 150 MM HA COATED HALF PIN; 1.6 MM CANNULATED; SST; REF 71070822; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 50 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 50 MM X 150 MM HA COATED HALF PIN SST; REF 71070810; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 55 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 55 MM X 150 MM HA COATED HALF PIN SST; REF 71070812; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 60 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 60 MM X 150 MM HA COATED HALF PIN SST; REF 71070814; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 65 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 65 MM X 150 MM HA COATED HALF PIN SST; REF 71070816; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 70 MM X 150 MM HA COATED HALF PIN SST – 6 MM X 70 MM X 150 MM HA COATED HALF PIN SST; REF 71070818; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 20 MM X 200 MM HA COATED HALF PIN SST – 6 MM X 20 MM X 200 MM HA COATED HALF PIN SST; REF 71070801; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 25 MM X 200 MM HA COATED HALF PIN SST – 6 MM X 25 MM X 200 MM HA COATED HALF PIN SST; REF 71070803; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 30 MM X 200 MM HA COATED HALF PIN SST – 6 MM X 30 MM X 200 MM HA COATED HALF PIN SST; REF 71070805; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6 MM X 35 MM X 200 MM HA COATED HALF PIN SST – 6 MM X 35 MM X 200 MM HA COATED HALF PIN SST; REF 71070807; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V – JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V; REF 71055451; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 20 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 20 MM SHORT HALF PIN TI-6AL-4V; REF 71056208; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 25 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 25 MM SHORT HALF PIN TI-6AL-4V; REF 71056258; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 30 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 30 MM SHORT HALF PIN TI-6AL-4V; REF 71056308; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 35 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 35 MM SHORT HALF PIN TI-6AL-4V; REF 71056358; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 40 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 40 MM SHORT HALF PIN TI-6AL-4V; REF 71056408; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V; REF 71056458; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 50 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 50 MM SHORT HALF PIN TI-6AL-4V; REF 71056508; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 55 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 55 MM SHORT HALF PIN TI-6AL-4V; REF 71056558; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 60 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 60 MM SHORT HALF PIN TI-6AL-4V; REF 71056608; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 65 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 65 MM SHORT HALF PIN TI-6AL-4V; REF 71056658; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 6 MM X 70 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 6 MM X 70 MM SHORT HALF PIN TI-6AL-4V; REF 71056708; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 5 MM X 20 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 5 MM X 20 MM SHORT HALF PIN TI-6AL-4V; REF 71055201; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 5 MM X 25 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 5 MM X 25 MM SHORT HALF PIN TI-6AL-4V; REF 71055251; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 5 MM X 30 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 5 MM X 30 MM SHORT HALF PIN TI-6AL-4V; REF 71055301; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 5 MM X 35 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 5 MM X 35 MM SHORT HALF PIN TI-6AL-4V; REF 71055351; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 5 MM X 40 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 5 MM X 40 MM SHORT HALF PIN TI-6AL-4V; REF 71055401; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 5 MM X 50 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 5 MM X 50 MM SHORT HALF PIN TI-6AL-4V; REF 71055501; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 5 MM X 55 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 5 MM X 55 MM SHORT HALF PIN TI-6AL-4V; REF 71055551; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 JET-X(R) 5 MM X 70 MM SHORT HALF PIN TI-6AL-4V – JET-X(R) 5 MM X 70 MM SHORT HALF PIN TI-6AL-4V; REF 71055701; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 5.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V – 5.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V; REF 71932948; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6.0 MM DIAMETER 25 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V – 6.0 MM DIAMETER 25 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V; REF 71932951; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6.0 MM DIAMETER 30 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V – 6.0 MM DIAMETER 30 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V; REF 71932952; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V – 6.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V; REF 71932953; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Smith & Nephew Inc Jun-06-2012 6.0 MM DIAMETER 40 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V – 6.0 MM DIAMETER 40 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V; REF 71932961; QTY: (1); STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116Orthopedic surgical device. Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch; voiding sterility.
Captiva Spine; Inc Jun-07-2012 Spinal Invervetebral Disc Space Orthosis – Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1; Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter; FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: info@captivaspine.com***"FPC – F is FuseLOX; P is Plif; C is ConvexProducts subject to recall: Convex – 7mm x 25mm Part Number: FPC2507 Lot Number 07110002. Convex – 8 mm x 25mm Part Number FPC2508 Lot Number 07110003. Convex – 9mm x 25mm Part Number: FPC2509 Lot Number 07110004.Convex – 10mm x 25mm Part Number: FPC2510 Lot Number 07110005. Convex – 11mm x 25mm Part Number: FPC2511 Lot Number 07110006. Convex – 12mm x 25mm Part Number: FPC2512 Lot Number 07110007. Convex – 13mm x 25mm Part Number FPC2513 Lot Number 07110008. Convex – 14mm x 25mm Part Number FPC2514 Lot Number 07110009. Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment.The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Captiva Spine; Inc. initiated a recall of FuseLOX Lumbar Implants; Trials; and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.
Captiva Spine; Inc Jun-07-2012 Spinal Invervetebral Disc Space Orthosis – Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Inserter products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment.FPT – F is FuseLOX; P is Plif; and I is Inserter. Products subject to recall: FuseLOX Lumbar Inserter Inserter – Part Number: FPT0200 Lot Number 6110100. Quantity distributed (8) is found in table on page 5 of 6. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Captiva Spine; Inc. initiated a recall of FuseLOX Lumbar Implants; Trials; and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.
Captiva Spine; Inc Jun-07-2012 Spinal Invervetebral Disc Space Orthosis – Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Trial products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment.FPT – F is FuseLOX; P is Plif; and T is Trial. Products subject to recall: FuseLOX Lumbar Trials Trial – 7mm x 25mm Part Number: FPT2507 Lot Number 8110001. Trial – 8mm x 25mm Part Number FPT2508 Lot Number 8110002. Trial – 9mm x 25mm Part Number: FPT2509 Lot Number 8110003.Trial – 10mm x 25mm Part Number: FPT2510 Lot Number 8110004. Trial – 11mm x 25mm Part Number: FPT2511 Lot Number 8110005. Trial – 12mm x 25mm Part Number: FPT2512 Lot Number 8110006. Trial – 13mm x 25mm Part Number FPT2513 Lot Number 8110007. Trial – 14mm x 25mm Part Number FPT2514 Lot Number 8110008. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Captiva Spine; Inc. initiated a recall of FuseLOX Lumbar Implants; Trials; and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.
Captiva Spine; Inc Jun-07-2012 Spinal Invervetebral Disc Space Orthosis – Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1; Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter; FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: info@captivaspine.com***"FPL – F is FuseLOX; P is Plif; C is Lorditic Products subject to recall: FuseLOX Lumbar Lorditic: Lorditic – 7mm x 25mm Part Number: FPL2507 Lot Number 07110010. Lorditic – 8mm x 25mm Part Number FPL2508 Lot Number 07110011. Lorditic – 9mm x 25mm Part Number: FPL2509 Lot Number 07110012.Lorditic – 10mm x 25mm Part Number: FPL2510 Lot Number 07110013. Lorditic – 11mm x 25mm Part Number: FPL2511 Lot Number 07110014. Lorditic – 12mm x 25mm Part Number: FPL2512 Lot Number 07110015. Lorditic – 13mm x 25mm Part Number FPL2513 Lot Number 07110016. Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment.The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Captiva Spine; Inc. initiated a recall of FuseLOX Lumbar Implants; Trials; and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.
Philips Medical Systems (Cleveland) Inc Jun-08-2012 The Brilliance iCT and iCT SP – The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories.The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0; 3.2.1 or 3.2.3; addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards.The nonconformance documented below had the highest sc
General Electric Med Systems LLC Jun-08-2012 Revolution XR/d – GE Healthcare Revolution XR/d; GE Healthcare; 3000 North Grandview ; Waukesha; WI; 53188Model numbers: 2259988-2 & 2351505.The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications. An incident was reported that an operator’s finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
General Electric Med Systems LLC Jun-08-2012 Definium 8000 – GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare; 3000 North Grandview ; Waukesha; WI; 53188Model Number: 5131070.The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use. An incident was reported that an operator’s finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
General Electric Med Systems LLC Jun-08-2012 Silhouette FC (currently marketed as Proteus XR/a) – GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee; WI.Model Number: 2259988.Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications. An incident was reported that an operator’s finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
MicroAire Surgical Instruments; LLC Jun-09-2012 Lipofilter 3000 – Lipofilter 3000; model ASP-CAN-2; labeled in part ***MicroAire; 1641 Edlich Drive; Charlottesville; VA 22911; USA***Product Usage:A fat collection canister intended for use during liposuction procedures. Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.
Plasma Surgical Inc. Jun-11-2012 PlasmaJet Open Surgery Handpiece – PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System)The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery. Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.
Integra LifeSciences Corp. Jun-12-2012 Integra – Integra Mozaik Putty2.5cc; 5 cc; 10 cc Product Usage:The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities; spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process. The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French;
Integra LifeSciences Corp. Jun-12-2012 Integra – Integra Mozaik Strip 10 cc Product Usage:The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities; spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process. The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French;
Philips Healthcare Inc. Jun-13-2012 Philips Healthcare Practix Convenio – Philips Healthcare Practix Convenio Mobile X-ray systemWorldwide Distribution — Nationwide When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off); a radiation pulse (50 kV; 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generatorswitch off); a radiation pulse (50 kV; 2.5 pGy) is generated inadvertently. The failure happened whencomponent supplie
Vygon Corporation Jun-13-2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes – Vygon VY(TM)Flush Heparin Lock Flush Syringes; 10 Units per mL; 3mL in a 10mL Flush Syringe; 30 syringes per box; Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes – Vygon VY(TM)Flush Heparin Lock Flush Syringes; 10 Units per mL; 5mL in a 10mL Flush Syringe; 30 syringes per box; Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes – Vygon VY(TM)Flush Heparin Lock Flush Syringes; 100 Units per mL; 3mL in a 10mL Flush Syringe; 30 syringes per box; Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes – Vygon VY(TM)Flush Heparin Lock Flush Syringes; 100 Units per mL; 5mL in a 10mL Flush Syringe; 30 syringes per box; Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Churchill Medical Systems; Inc. A VYGON COMPANY PICC INSERTION TRAY – Churchill Medical Systems; Inc. A VYGON COMPANY PICC INSERTION TRAYPrefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Churchill Medical Systems; Inc. PORT-A-CATH Tray Kit – Churchill Medical Systems; Inc. PORT-A-CATH Tray KitPrefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Churchill Medical Systems; Inc. A VYGON Company PICC INSERTION TRAY Kit – Churchill Medical Systems; Inc. A VYGON Company PICC INSERTION TRAY KitPrefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Churchill Medical Systems; Inc. VAD ACCESS TRAY Kit – Churchill Medical Systems; Inc. VAD ACCESS TRAY KitPrefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Churchill Medical Systems; Inc. VAD ACCESS TRAY Kit – Churchill Medical Systems; Inc. VAD ACCESS TRAY KitPrefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Churchill Medical Systems; Inc. DRESSING CHANGE KIT – Churchill Medical Systems; Inc. DRESSING CHANGE KITPrefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes – Vygon VY(TM)Flush Heparin Lock Flush Syringes; 1 Unit per mL; 3mL in a 10mL Flush Syringe; 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon Corporation Jun-13-2012 Churchill Medical Systems; Inc. A VYGON Company PICC LINE TRAY Kit – Churchill Medical Systems; Inc. A VYGON Company PICC LINE TRAY KitPrefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Stryker Instruments Div. of Stryker Corporation Jun-14-2012 T4 Hytrel Zipper Toga – T4-Hytrel Zipper Toga Product Usage – The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The clear tape; that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga; was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
Stryker Instruments Div. of Stryker Corporation Jun-14-2012 T5 Hytrel Zipper Toga – T5 Hytrel Zipper Toga. Product Usage:The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The clear tape; that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga; was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
Stryker Howmedica Osteonics Corp. Jun-15-2012 Stryker Howmedica Osteonics Accolade Offset Rasp Handle – Stryker Howmedica Osteonics Accolade Offset Rasp HandleHowmedica Osteonics Corp. 325 Corporate Drive; Mahwah; NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex FranceSingle offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue. Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
Philips Healthcare Inc. Jun-15-2012 Philips Healthcare Imaging – Philips Digital Diagnost Software; software release 2.0.2 and 2.0.2SP1 including mirror iconStationary Fluoroscopic system With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system; an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "right patient side" marker; although this can appear on the left patient side
Non-Invasive Monitoring Systems; Inc. Jun-18-2012 Ever-Rest US Brochure US-001 Rev A. – US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use; precautions and general operational information of the Exer-Rest device; Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research…***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax; thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd.; Miami; FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS; Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems; Inc.***US-001 Rev A***"Printed marketing brochure Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Ultradent Products; Inc. Jun-18-2012 Peak SE Primer Refill – Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products; Inc; South Jordan; UT; Self Etch Primer. The product is contained within prefilled; labeled syringes in a transparent plastic container identified with an aqua; red; orange; blue and black label with black and blue print writing. Product code: 5135; 872.3200 KLE; liquid and powder mixture is a syringe-in-a-syringe delivery system.The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites; namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel; porcelain; metal and composite. Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint; dated May 10; 2012; stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures.
Philips Healthcare Inc. Jun-18-2012 Easy Diagnost – Philips Easy DiagnostProduct Usage: Stationary Fluoroscopic system If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured; measured object distances (using the ruler) can be wrong by a corresponding factor. If; additionally; the measurement tool is not used to check the ruler; or is used in the right way (ie: calibration); such calibration error is not detected. As a result of this; a surgical intervention may be execut
Non-Invasive Monitoring Systems; Inc. Jun-18-2012 Exer-Rest Brochures USA-002 Rev A – USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use; precautions and general operational information of the Exer-Rest device; Models AT3800 and AT4700. Brochure: "EXER-REST***A patented; FDA registered; Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body; a process called pulsatile shear stress; to promote the release of beneficial substances (mediators). These mediators; such as nitric oxide; provide a wide range of health benefits that originate from the user’s own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax; thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd.; Miami; FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS; Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems; Inc.***USA-002 Rev A***"Printed marketing brochure Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Arrow International Inc Jun-19-2012 Arrow International; Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Cat – Arrow International; Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter – Catalog number CDC-42703-XP1AThe multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections. Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.
App Pharmaceuticals Llc Jun-19-2012 HEPARIN LOCK FLUSH SOLUTION – HEPARIN LOCK FLUSH SOLUTION; USP; 10 USP Units/mL; 1 mL Multiple Dose Vial; plastic vial; vial size 3 mL; NDC 63323-544-01; Product Code 504401; Rx onlyTo maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling. CGMP Deviations: Incomplete documentation associated with test results.
App Pharmaceuticals Llc Jun-19-2012 HEPARIN LOCK FLUSH SOLUTION – HEPARIN LOCK FLUSH SOLUTION; USP; 100 USP Units/mL; 1 mL Multiple Dose Vial; plastic vial; vial size 3 mL; NDC 63323-545-01; Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION; USP; 100 USP Units/mL; 5 mL Multiple Dose Vial; 500 USP Units/5 mL; plastic vial; vial size 6 mL; NDC 63323-545-05; Product Code 504505; Rx onlyTo maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling. CGMP Deviations: Incomplete documentation associated with test results.
Philips Healthcare Inc. Jun-20-2012 Philips Multi Diagnost Eleva II with swivel cable – Philips Multi Diagnost Eleva II with swivel cableProduct Codes;708032; 708036Multi Diagnost Eleva with FlatDetector with swivel cableProduct Codes: 708034; 708037This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F; performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy; Radiography and Angiography MultiDiagnost Eleva X–Ray system may have damage to System Cables from repeated movement
Natus Medical Incorporated Jun-20-2012 Olympic Cool-Cap System – Olympic Cool-Cap System is intended to provide treatment forneonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant’s head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling.The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***" Olympic Cool-Cap Cooling Module’s power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
Spacelabs Healthcare; Llc Jun-20-2012 Spacelabs Healthcare Pathfinder SL Holter Analyzer – The product is Pathfinder SL; version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer; version 1.6.0.Product Usage:The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition; incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message. The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition; QTc values will not update after moving the marker.
Terumo Cardiovascular Systems Corporation Jun-20-2012 SARNS FLEXIBLE ARTERIAL CANNULA – SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR;SUTURE RING; 9.5" (24 CM) LONG.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 SARNS FLEXIBLE ARTERIAL CANNULA – SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR;SUTURE RING; 9.5" (24 CM) LONG.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 SARNS FLEXIBLE ARTERIAL CANNULA – SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR; CM MARKING; 10" (25 CM) LONG.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 24FR FLEX ART CANN NON STERILE – 24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 SPECIALTYCARE – HUDGENS. – SPECIALTYCARE – HUDGENS.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 CUSTOM CPB CATHETER KIT-DR – CUSTOM CPB CATHETER KIT-DR.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 CPB CATHETER KIT- DR.VAN TRIGHT – CPB CATHETER KIT- DR.VAN TRIGHT.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 SARNS FLEXIBLE ARTERIAL CANNULA – SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR;SUTURE RING; 9.5" (24 CM) LONG.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 SARNS HIGH-FLOW AORTIC ARCH CANNULA – SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR; 11" (28 CM) LONG; WITH XCOATING SURFACE COATING.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 SARNS HIGH-FLOW AORTIC ARCH CANNULA – SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR; 11" (28 CM) LONG.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Terumo Cardiovascular Systems Corporation Jun-20-2012 SARNS HIGH-FLOW AORTIC ARCH CANNULA – SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR; 7.5" (19 CM) LONG.The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During production of one lot of the Sarns High-Flow Aortic Arch Cannula; Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface; the substance was likely deposited during the molding process; but the exact composition of the parti
Biomet 3i; LLC Jun-20-2012 Endosseous Dental Implants – Implant; Dental; Endosseous; Acid Etched; ICE; Osseotite; Internal Connection. . Product is labeled in part: "***Certain 3.25; 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.***Product Usage:The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. On November 3; 2011 Biomet 3i; Palm Beach Gardens; FL initiated a recall of their Osseotite Certain Implant; Model # IOSM313; Lot #2010111529. Dental implant lot may not have an internal thread.
Accumetrics Inc Jun-21-2012 VERIFYNOW-P2Y12 ASSAY – VerifyNow System; part #85005-6HProduct Usage:The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator. The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU; BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic
Genzyme Corporation Jun-21-2012 Genzyme – seprafilm¿ Single Site ADHESION BARRIERRe-order Number: 6641-01Product Usage:Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence; extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum; small bowel; bladder; and stomach; and between the uterus and surrounding structures such as tubes and ovaries; large bowel; and bladder. Sterility of product may be compromised due to packaging defect
Accumetrics Inc Jun-21-2012 VERIFYNOW-P2Y12 ASSAY – VerifyNow P2Y12 Assay; Part Number: 85064; All reagent lots.Product Usage:The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator. The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU; BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic
Genzyme Corporation Jun-21-2012 Genzyme – seprafilm¿ Procedure Pack ADHESION BARRIERRe-order Number: 5086-02Product Usage:Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence; extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum; small bowel; bladder; and stomach; and between the uterus and surrounding structures such as tubes and ovaries; large bowel; and bladder. Sterility of product may be compromised due to packaging defect
Covidien LP Jun-21-2012 ROTICULATOR Single Use Stapler – Covidien ROTICULATOR 30-3.5 Single Use StaplerREF# 017615The RETICULA TOR TM Single Use Staplers have applications in abdominal; gynecologic and pediatric surgery for resection; transection; and creation of anastomosis Potential for the sterility barrier to be compromised.
Covidien LP Jun-21-2012 ROTICULATOR Single Use Stapler – Covidien ROTICULATOR 30-4.8 Single Use StaplerREF# 017617The RETICULA TOR TM Single Use Staplers have applications in abdominal; gynecologic and pediatric surgery for resection; transection; and creation of anastomosis Potential for the sterility barrier to be compromised.
Covidien LP Jun-21-2012 ROTICULATOR Single Use Stapler – Covidien ROTICULATOR 30-V3 Single Use StaplerREF# 017619The RETICULA TOR TM Single Use Staplers have applications in abdominal; gynecologic and pediatric surgery for resection; transection; and creation of anastomosis Potential for the sterility barrier to be compromised.
Covidien LP Jun-21-2012 ROTICULATOR Single Use Stapler – Covidien ROTICULATOR 55-3.5 Single Use StaplerREF# 017612The RETICULA TOR TM Single Use Staplers have applications in abdominal; gynecologic and pediatric surgery for resection; transection; and creation of anastomosis Potential for the sterility barrier to be compromised.
Boston Scientific Corporation Jun-21-2012 Boston Scientific Profile Single-Use Pediatric Snare – Boston Scientific Profile Single-Use Pediatric Snare 27mmUPN Outer Box: M00562571Inner Pouch: M00562570The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare’s flexible outer sheath using a three-ring handle. When passed through an endoscope and activated; the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop Difficulty in extending snare loop from the catheter
Boston Scientific Corporation Jun-21-2012 Boston Scientific Profile Single-Use Pediatric Snare – Boston Scientific Profile Single-Use Pediatric Snare 13mmUPN Outer Box: M00562551Inner Pouch: M00562550The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare’s flexible outer sheath using a three-ring handle. When passed through an endoscope and activated; the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop Difficulty in extending snare loop from the catheter
Boston Scientific Corporation Jun-21-2012 Boston Scientific Profile Single-Use Pediatric Snare – Boston Scientific Profile Single-Use Pediatric Snare 11mmUPN Outer Box M00562531Inner Pouch: M00562530 ;The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare’s flexible outer sheath using a three-ring handle. When passed through an endoscope and activated; the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop Difficulty in extending snare loop from the catheter
Covidien LP Jun-21-2012 ROTICULATOR Single Use Stapler – Covidien ROTICULATOR 55-4.8 Single Use StaplerREF# 017614The RETICULA TOR TM Single Use Staplers have applications in abdominal; gynecologic and pediatric surgery for resection; transection; and creation of anastomosis Potential for the sterility barrier to be compromised.
Medtronic Navigation; Inc. Jun-21-2012 O-ARM Imaging System – Medtronic 0-arm Imaging System with Software Version 3.1.1; Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging. Software Version 3.1.1 does not meet navigational accuracy.
Hill-Rom; Inc. Jun-22-2012 Advanta 2 Bed. – Advanta 2 Bed.The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital. During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.
Hartmann USA; Inc Jun-22-2012 Econolux – Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total spongesFor use in wound cleansing; debriding of wounds; wound packing; covering and swabbing Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
GE OEC Medical Systems; Inc Jun-22-2012 OEC Uroview 2800 – OEC Uroview 2800; Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic; surgical; and interventional procedures. Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy; system Lok-up; incorrect image display; incorrect dose area calculated air kerma in "film mode" and "digital spot mode"; and the system does not reboot.
Hartmann USA; Inc Jun-22-2012 Sterilux – Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total spongesFor use in wound cleansing; debriding of wounds; wound packing; covering and swabbing Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Stryker Medical Division of Stryker Corporation Jun-22-2012 Go Bed II Model FL 28 Ex – Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient; or caregiver; to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E; FL25E; FL28C; FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+; GoBed II; Rose; and MA204 model beds. Investigation found an abnormally high failure rate of loadcells; an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading; a scale error causing the scale system to be disabled until serviced; or an inac
Stryker Medical Division of Stryker Corporation Jun-22-2012 Stryker GoBed+ – GoBed+ . Model FL20EBeds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient; or caregiver; to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E; FL25E; FL28C; FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+; GoBed II; Rose; and MA204 model beds. Investigation found an abnormally high failure rate of loadcells; an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading; a scale error causing the scale system to be disabled until serviced; or an inac
Stryker Medical Division of Stryker Corporation Jun-22-2012 Stryker MA204 – Stryker MA204 Bed Model (FL25E)Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient; or caregiver; to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E; FL25E; FL28C; FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+; GoBed II; Rose; and MA204 model beds. Investigation found an abnormally high failure rate of loadcells; an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading; a scale error causing the scale system to be disabled until serviced; or an inac
Stryker Medical Division of Stryker Corporation Jun-22-2012 Stryker Rose Bed – Stryker Rose Bed Model (FL14E)Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient; or caregiver; to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E; FL25E; FL28C; FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+; GoBed II; Rose; and MA204 model beds. Investigation found an abnormally high failure rate of loadcells; an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading; a scale error causing the scale system to be disabled until serviced; or an inac
Stryker Medical Division of Stryker Corporation Jun-22-2012 Stryker GoBed II – Go Bed II+ Model FL28C Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient; or caregiver; to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E; FL25E; FL28C; FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+; GoBed II; Rose; and MA204 model beds. Investigation found an abnormally high failure rate of loadcells; an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading; a scale error causing the scale system to be disabled until serviced; or an inac
Stryker Endoscopy Jun-25-2012 Formula 180 Shaver Hand Control – Formula Shaver Handpiece (with buttons);Formula 180 Shaver Handpiece (with button)Rx only; Made USA.:Stryker Endoscopy5900 Optical CourtSan Jose; CA 95138Components within the Crossfire System that provided abrasion; resection; debridement and removal of bone and soft tissue through the Formula Shaver and blade; and the ablation and coagulation of soft tissue; as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe. Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.
Medical Components; Inc dba MedComp Jun-26-2012 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Cathet – MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter.Power Injectable Implantable Infusion Port insertion kit. Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
Siemens Healthcare Diagnostics; Inc. Jun-26-2012 BCS(R) Behring Coagulation System – BCS(R) Behring Coagulation System; Device catalog No. OVIO03Product Usage:Multipurpose system for In Vitro coagulation studies Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit; and the test immediately following is an APTT based clotting assay several results may be shortened.
Colgate Palmolive Company Jun-27-2012 Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft – Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft UPC 03500068762 Dist. byColgate-Palmolive Co.New York; NY 10022Made in China.For teeth cleansing. Brush battery cap was forcibly blown off at the end of the brush handle.
Colgate Palmolive Company Jun-27-2012 Colgate 360 Replaceable Head Battery Powered Toothbrush Soft – Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist. byColgate-Palmolive Co.New York; NY 10022Made in China.For teeth cleansing. Brush battery cap was forcibly blown off at the end of the brush handle.
Colgate Palmolive Company Jun-27-2012 Colgate 360 Replaceable Head Battery Powered Toothbrush Medium – Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist. byColgate-Palmolive Co.New York; NY 10022Made in China.For teeth cleansing. Brush battery cap was forcibly blown off at the end of the brush handle.
Colgate Palmolive Company Jun-27-2012 Colgate Adult Motion Whitening Battery Toothbrush – Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507Dist. byColgate-Palmolive Co.New York; NY 10022Made in China.For teeth cleansing. Brush battery cap was forcibly blown off at the end of the brush handle.
Colgate Palmolive Company Jun-27-2012 Colgate Adult Motion Battery Toothbrush – Colgate Adult Motion Battery Toothbrush UPC 035000686213Dist. byColgate-Palmolive Co.New York; NY 10022Made in China.For teeth cleansing. Brush battery cap was forcibly blown off at the end of the brush handle.
Zimmer; Inc. Jun-27-2012 Bigliani/Flatow-The Complete Shoulder Solution Trabecular Metal Glenoid Instr Drill w/Stop – Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop; 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder. Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop; 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00; lot 62071190.
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – X-COATED TRANSPLANT PACKProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – X-COATED SMALL PATIENT PACKProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – X-COATED SMALL PATIENT PACKProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – MAYO MN XCOATED 3/8X1/2 AVProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – X-COATED FX25RW H/L PACKProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – X-COATED H/L PK W/FX15RW40Product Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – CUSTOM CPB CATHETER KIT-DR.Product Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – CPB CATHETER KIT-DR GERHARDTProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – CPB CATHETER KIT- DR OWENProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – CPB CATHETER KIT- DR HENDRICKSOProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – CPB CATHETER KIT-DR VANTRIGHTProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – CPB CATHETER KIT-DR VANTRIGHTProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – CPB CATHETER KIT-DR BARTLESProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – XC HEART/LUNG PACK W/SX25RXProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – INDIANA/OHIO HEARTProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – FX PACKProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE;RECTANGULAR FLANGE AND SUTURE COLLAR; 6" (15CM) LONGProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE;RECTANGULAR FLANGE AND SUTURE COLLAR; 6" (15CM) LONGProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE; RECTANGULAR FLANGE; 6" (15 CM) LONGProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Terumo Cardiovascular Systems Corporation Jun-27-2012 Sarns – Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE; 6" (15 CM) LONGProduct Usage:The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart; to vent the left heart; and to aspirate air from the aorta during cardiopulmonary bypass procedures. During production of the Sarns Antegrade Cardioplegia Cannula; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips.Terumo CVS’ preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process; but the exact composition of the
Sekisui Diagnostics Llc Jun-27-2012 MULTIGENT Acetaminophen for use with Architect/Aeroset – MULTIGENT Acetaminophen for use with Architect/AerosetCat. No. 2K99-20.Assay is intended for the quantitative determination of acetaminophen in human serum or plasma. Discoloration of the acetaminophen enzyme reagent (R1); generates a high calibration factor and erratic control recovery.
Ethicon; Inc. Jun-27-2012 Ethicon – Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex TipDistributed by Ethicon Ethicon Inc.; Somerville; NJ 08876 USAManufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/SSydmarken 5; DK-2860 Soeberg; DenmarkMixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary; venous and arteriolar bleeding by pressure; ligature; and other conventional procedures is ineffective or impractical. They lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process.
SALTER LABS Jun-27-2012 Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector – Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector.7 ft; oxygen tube; 7 ft. CO2 tubeRX only.For Single Patient Use only.Distributed by Tri-AniumAssembled in Mexico.Usage: Delivery of Anesthesia. A complaint was received; and later verified; that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector.
Philips Healthcare Inc. Jun-27-2012 Philips HeartStart MRx – Philips HeartStart MRx monitor/defibrillatorsModels: M3535A; M3536A; M3536M4; M3536M5; and M3536M6Product Usage:The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac support; or defibrillation. It must be used by or on the order of a physician HeartStart MRx Unexpected Pads/Paddles ECG Failure
Siemens Healthcare Diagnostics; Inc. Jun-27-2012 Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge – Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442)B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma. Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elevation in the reported concentration of Vitamin B12 on the Dimension Vista System. This issue affects all lots of B12 Flex reagent cartridges on the Dimension Vista System.
Polymer Technology Systems; Inc. Jun-28-2012 PTS Panels Creatinine test strips. – PTS Panels Creatinine test strips.PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample During a routine product investigation; a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl; which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.
Abbott Laboratories Jun-29-2012 ARCHITECT CA 19-9XR Reagent Kit – ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit; list 2K91-20 (4 x 100 tests); 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage:The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods. The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.
Invacare Corporation Jun-29-2012 TDX SP Power Wheelchair; TDX SR Power Wheelchair; TDX SI Power Wheelchair – TDX SP Power Wheelchair; TDX SR Power Wheelchair; TDX SI Power Wheelchair. Model Number(s): TDXSI; TDXSI-2; TDXSI-2-S; TDXSI-CG; TDXSI-HD; TDXSI-HD-S; TDXSIV; TDXSIV-2; TDXSIV-2-S; TDXSIV-HD; TDXSIV-HD-S; TDXSP; TDXSPBASE; TDXSP-CG; TDXSPEURO; TDXSP-MCG; TDXSP-MCG-GT; TDXSR; TDXSR-CG; TDXSR-CG-HD; TDXSR-MCG; FDX; FDX-CG; FDXEURO-14; FDX-MCG. Mrf. By: Invacare Corporation; 1200 Taylor Street; Elyria; OH 44035.Intended to provide mobility to a person restricted to a sitting position. Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse.
DePuy Orthopaedics; Inc. Jun-29-2012 ULTIMA*LX STM – ULTIMA*LX STM;POL 10/12TAP/SZ4Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 ULTIMA*LX STM – ULTIMA*LX STM;POL 10/12TAP/SZ5Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 ULTIMA*LX STM – ULTIMA*LX STM;POL 10/12TAP/1MPackaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 ULTIMA*LX STM – ULTIMA*LX STM;POL 10/12TAP/2MPackaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 ULTIMA*LX STM – ULTIMA*LX STM;POL 10/12TAP/3MPackaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 ULTIMA*LX STM – ULTIMA*LX STM;POL 10/12TAP/4MPackaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 1Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 2Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 3Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 4Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 5Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 6Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 7Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 8Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 9Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 LUSTER HIP – LUSTER HIP SZ 10Packaging: The product was packaged within inner and outer blister trays; sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors; with foam taper protectors.Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 ULTIMA*LX STM – ULTIMA*LX STM;POL 10/12TAP/SZ3Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 ULTIMA*LX STM – ULTIMA*LX STM;POL 10/12TAP/SZ2Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
DePuy Orthopaedics; Inc. Jun-29-2012 ULTIMA*LX STM – ULTIMA*LX STM;POL 10/12TAP/SZ1Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups. DePuy Orthopaedics; Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U