Category

Medical Implants Recalls

1,784 medical implants recalls on record from CPSC, FDA, and USDA.

1,784 recalls
High RiskFDA
Howmedica Osteonics Corp.
rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head ...
Medical Implants·19 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead R...
Medical Implants·133 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHe...
Medical Implants·605 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and ...
Medical Implants·170 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial ...
Medical Implants·163 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radia...
Medical Implants·301 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
radial head implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radia...
Medical Implants·628 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Ra...
Medical Implants·118 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead ...
Medical Implants·283 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial H...
Medical Implants·245 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead ...
Medical Implants·396 affected·Oct 24, 2017
High RiskFDA
Zimmer Dental Inc
Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous...
Medical Implants·356 affected·Oct 11, 2017
High RiskFDA
Zimmer Dental Inc
Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimme...
Medical Implants·30 affected·Oct 11, 2017
High RiskFDA
Zimmer Dental Inc
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product i...
Medical Implants·891 affected·Oct 11, 2017
High RiskFDA
W L Gore & Associates, Inc.
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesi...
Medical Implants·12,197 affected·Sep 25, 2017
RecallFDA
Medtronic Neuromodulation
Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8...
Medical Implants·194 affected·Sep 21, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee S...
Medical Implants·10 affected·Sep 14, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Medical Implants·3,119 affected·Sep 12, 2017
High RiskFDA
Zoll Manufacturing Corp.
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age ...
Medical Implants·33,670 affected·Sep 12, 2017
High RiskFDA
Howmedica Osteonics Corp.
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to i...
Medical Implants·130 affected·Sep 8, 2017
High RiskFDA
Limacorporate S.p.a
Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Medical Implants·20 affected·Sep 8, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulde...
Medical Implants·0 affected·Aug 31, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-sho...
Medical Implants·23,053 affected·Aug 31, 2017
High RiskFDA
St Jude Medical Inc.
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is i...
Medical Implants·164,366 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to b...
Medical Implants·101 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI...
Medical Implants·529,912 affected·Aug 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implan...
Medical Implants·1,275 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transm...
Medical Implants·495,011 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse ge...
Medical Implants·2,741 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a porta...
Medical Implants·10,453 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a sin...
Medical Implants·102,684 affected·Aug 28, 2017
High RiskFDA
Biomerieux Inc
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, softwar...
Medical Implants·11,703 affected·Aug 25, 2017
High RiskFDA
Zimmer Biomet, Inc.
G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joi...
Medical Implants·8 affected·Aug 25, 2017
High RiskFDA
Medtronic Neuromodulation
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 863...
Medical Implants·27,547 affected·Aug 9, 2017
High RiskFDA
Zimmer Biomet, Inc.
Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a pro...
Medical Implants·842 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
Medical Implants·842 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a pros...
Medical Implants·842 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthe...
Medical Implants·842 affected·Aug 7, 2017
High RiskFDA
Orthofix, Inc
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decor...
Medical Implants·6 affected·Aug 2, 2017
High RiskFDA
Smith & Nephew, Inc.
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Medical Implants·27 affected·Aug 1, 2017
High RiskFDA
Cardinal Health 200, Llc
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I...
Medical Implants·184,102 affected·Aug 1, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricu...
Medical Implants·72 affected·Jul 24, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricul...
Medical Implants·68 affected·Jul 24, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only ...
Medical Implants·402 affected·Jul 24, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricu...
Medical Implants·86 affected·Jul 24, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Medical Implants·50 affected·Jul 21, 2017
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a ...
Medical Implants·1,519,984 affected·Jul 14, 2017
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an ext...
Medical Implants·1,519,984 affected·Jul 14, 2017