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1,784 recalls
High RiskFDA
Nobel Biocare Usa Llc
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical C...
Medical Implants·231 affected·Jul 20, 2016
High RiskFDA
Straumann Manufacturing, Inc.
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
Medical Implants·33 affected·Jul 14, 2016
RecallFDA
Zimmer Trabecular Metal Technology, Inc.
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine....
Medical Implants·299 affected·Jul 7, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minim...
Medical Implants·1 affected·Jun 30, 2016
High RiskFDA
Tyrx Inc.
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardi...
Medical Implants·3,460 affected·Jun 29, 2016
High RiskFDA
Zimmer Gmbh
V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant syst...
Medical Implants·169 affected·Jun 27, 2016
High RiskFDA
Zimmer Gmbh
V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant syst...
Medical Implants·169 affected·Jun 27, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the s...
Medical Implants·47 affected·Jun 23, 2016
High RiskFDA
Medtronic Neuromodulation
DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a par...
Medical Implants·7,542 affected·Jun 23, 2016
High RiskFDA
Nobel Biocare Usa Llc
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended t...
Medical Implants·53 affected·Jun 22, 2016
High RiskFDA
Anthogyr
Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can b...
Medical Implants·10 affected·Jun 20, 2016
High RiskFDA
Synthes (usa) Products Llc
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904...
Medical Implants·383 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synt...
Medical Implants·36 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe...
Medical Implants·19 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Produ...
Medical Implants·79 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usag...
Medical Implants·18 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synt...
Medical Implants·18 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Pro...
Medical Implants·75 affected·May 31, 2016
High RiskFDA
Pentax Of America Inc
Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic...
Medical Implants·113 affected·May 31, 2016
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that int...
Medical Implants·262 affected·May 26, 2016
High RiskFDA
Ev3, Inc.
EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex"...
Medical Implants·2 affected·May 23, 2016
High RiskFDA
Merz North America, Inc.
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for s...
Medical Implants·1,591 affected·May 20, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tr...
Medical Implants·48 affected·May 19, 2016
High RiskFDA
Zimmer Gmbh
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem...
Medical Implants·177 affected·May 17, 2016
High RiskFDA
Zimmer Biomet, Inc.
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implant...
Medical Implants·10,256 affected·May 11, 2016
High RiskFDA
Cordis Corporation
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Medical Implants·4,400 affected·May 4, 2016
High RiskFDA
Medtronic Neuromodulation
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chr...
Medical Implants·60,941 affected·May 3, 2016
High RiskFDA
Integra Lifesciences Corp.
Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, ther...
Medical Implants·12 affected·Apr 29, 2016
High RiskFDA
B. Braun Medical, Inc.
WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Nu...
Medical Implants·5,980 affected·Apr 26, 2016
High RiskFDA
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a singl...
Medical Implants·630 affected·Apr 21, 2016
High RiskFDA
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single...
Medical Implants·315 affected·Apr 21, 2016
High RiskFDA
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single...
Medical Implants·707 affected·Apr 21, 2016
High RiskFDA
Stanmore Implants Worldwide Ltd.
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Medical Implants·1 affected·Apr 12, 2016
High RiskFDA
Stryker Corporation
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) an...
Medical Implants·3,100 affected·Apr 12, 2016
High RiskFDA
Limacorporate S.p.a
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Medical Implants·314 affected·Apr 8, 2016
High RiskFDA
Pentax Medical Company
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. T...
Medical Implants·0 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes...
Medical Implants·4,195 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includ...
Medical Implants·12,412 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult trachea...
Medical Implants·1,220 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. T...
Medical Implants·12,412 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus...
Medical Implants·96 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds....
Medical Implants·206 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic acce...
Medical Implants·819 affected·Apr 6, 2016
High RiskFDA
Nuvectra
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems....
Medical Implants·17 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy inclu...
Medical Implants·1,596 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmona...
Medical Implants·115 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Ga...
Medical Implants·819 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. T...
Medical Implants·10,074 affected·Apr 6, 2016