Medical Device Recalls

CFRES ID Product Res No Recall Status Product Code Event Date Initiated Recalling Firm Product Description
93275 Z-2583-2010 Terminated MQP 2010-07-23 Synthes USA (HQ), Inc. SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.
93837 Z-2604-2010 Terminated LXH 2010-07-01 Biomet, Inc. 10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
94026 Z-2558-2010 Terminated FMI 2010-08-30 Multi-Med, Inc. Marquette Medical Huber Trap-A Safety Huber Needle 20ga x .75" Winged Administration Set w/Y Site Model # MWS203 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
93914 Z-2513-2010 Terminated FMI 2010-08-30 Multi-Med, Inc. All Med Medical 20ga x .50" Winged Administration Set Model # M205 Reorder # 50-2011
94301 Z-2592-2010 Terminated FRN 2010-09-02 Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of medication and narcotics.
92137 Z-2304-2010 Terminated GEI 2010-06-07 DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Hook Electrode (integrated) Product Code: 227305 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9¿ and S ¿) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
92073 Z-1990-2010 Terminated FGE 2010-04-27 Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-5cm, M00539350, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
93120 Z-2272-2010 Terminated MAV 2010-07-16 Medtronic, Inc. Medtronic¿ Everest¿ 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
92069 Z-1986-2010 Terminated FGE 2010-04-27 Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-7cm, M00539310, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
93896 Z-2285-2010 Terminated KNW 2010-08-11 Hologic, Inc. Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted into the breast to the site of interest. When the proper location/position is acheived, the handpiece cuts and removes biopsy tissue.
92977 Z-2249-2010 Terminated KDC 2010-01-28 Linvatec Corp. dba ConMed Linvatec REF 9903, DIGIT TRAP FINGER GRASPING DEVICE, LARGE STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in small joint arthroscopic procedures.
92061 Z-197-2010 Terminated FGE 2010-04-27 Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
92142 Z-2309-2010 Terminated GEI 2010-06-07 DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Temperature Control Electrode (integrated Product Code: 227252 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9¿ and S ¿) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
93305 Z-2295-2010 Terminated LON 2010-07-29 Biomerieux Inc VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMerieux, sa, France.This is an Export Only test kit that is not marketed in the U.S.
92982 Z-2253-2010 Terminated HRX 2010-01-28 Linvatec Corp. dba ConMed Linvatec REF C4000 INTEQ TFCC SMALL JOINT SUTURING SYSTEM KITS, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
92065 Z-1982-2010 Terminated FGE 2010-04-27 Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-10cm, M00539270, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
93971 Z-2450-2010 Terminated GAZ 2010-08-16 Cardinal Health Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per case; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N56A and NEX56A (European label)
93313 Z-2493-2010 Terminated FOZ 2010-07-29 Arrow International Inc Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions
94169 Z-2481-2010 Terminated DTQ 2010-09-10 Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. (This product is not distributed in the US)
90826 Z-2438-2010 Terminated JQP 2010-04-09 International Technidyne Corporation Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854
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