Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
Medtronic Neuromodulation
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an inf...
Medical Implants·1 affected·May 2, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is p...
Medical Implants·22 affected·May 1, 2014
High RiskFDA
Synthes, Inc.
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0...
Medical Implants·6,690 affected·Apr 29, 2014
CriticalFDA
Heraeus Kulzer, Llc.
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed...
Medical Implants·5,112 affected·Apr 23, 2014
High RiskFDA
Heartware Inc
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantati...
Medical Implants·32,349 affected·Apr 16, 2014
High RiskFDA
Medtronic Neuromodulation
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usa...
Medical Implants·13,784 affected·Apr 4, 2014
High RiskFDA
Zimmer, Inc.
TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
Medical Implants·17 affected·Apr 1, 2014
High RiskFDA
Acumed Llc
The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Numbe...
Medical Implants·141 affected·Mar 26, 2014
High RiskFDA
Teleflex Medical
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used...
Medical Implants·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone ...
Medical Implants·32,271 affected·Mar 11, 2014
High RiskFDA
Exactech, Inc.
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replac...
Medical Implants·10 affected·Mar 7, 2014
High RiskFDA
Pega Medical Inc.
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. ...
Medical Implants·48 affected·Mar 5, 2014
CriticalFDA
Thoratec Corporation
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the ...
Medical Implants·4,120 affected·Mar 4, 2014
High RiskFDA
Bard Access Systems
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 171600...
Medical Implants·777 affected·Feb 27, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CO...
Medical Implants·3,638 affected·Feb 25, 2014
High RiskFDA
Pega Medical Inc.
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue...
Medical Implants·5 affected·Feb 7, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Rig...
Medical Implants·48 affected·Feb 3, 2014
CriticalFDA
Greatbatch Medical
Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T...
Medical Implants·4,870 affected·Jan 31, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation...
Medical Implants·169 affected·Jan 28, 2014
High RiskFDA
Synthes, Inc.
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fix...
Medical Implants·18,747 affected·Jan 27, 2014
High RiskFDA
Smith & Nephew Inc
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented...
Medical Implants·10 affected·Jan 23, 2014
High RiskFDA
Atricure Inc
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Appli...
Medical Implants·46 affected·Jan 23, 2014
High RiskFDA
Integra Lifesciences Corp.
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): ...
Medical Implants·40 affected·Jan 22, 2014
High RiskFDA
Zest Anchors Llc
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous i...
Medical Implants·3,130 affected·Jan 16, 2014
High RiskFDA
Zimmer, Inc.
00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabec...
Medical Implants·10 affected·Jan 10, 2014
High RiskFDA
Mako Surgical Corporation
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic Sys...
Medical Implants·41 affected·Jan 9, 2014
High RiskFDA
Medtronic Cardiovascular Surgery-the Heart Valve Division
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Medical Implants·8,276 affected·Jan 9, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable steri...
Medical Implants·46 affected·Jan 3, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable ste...
Medical Implants·19 affected·Jan 3, 2014
High RiskFDA
Zimmer, Inc.
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip Sys...
Medical Implants·36 affected·Dec 10, 2013
High RiskFDA
Bard Access Systems
Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr ...
Medical Implants·200 affected·Dec 6, 2013
CriticalFDA
Heartware Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use...
Medical Implants·4,586 affected·Dec 6, 2013
High RiskFDA
Navilyst Medical, Inc.
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; ...
Medical Implants·920 affected·Nov 25, 2013
High RiskFDA
Concentric Medical Inc
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in th...
Medical Implants·10 affected·Nov 13, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cem...
Medical Implants·87 affected·Nov 1, 2013
High RiskFDA
Zimmer, Inc.
NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-const...
Medical Implants·128 affected·Oct 31, 2013
High RiskFDA
Orthofix, Inc
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anter...
Medical Implants·4,172 affected·Oct 29, 2013
High RiskFDA
Nobel Biocare Usa Llc
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set O...
Medical Implants·1,082 affected·Oct 24, 2013
High RiskFDA
Ossur North America Inc
Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from th...
Medical Implants·66 affected·Oct 24, 2013
High RiskFDA
Carl Zeiss Meditec, Inc.
Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), ...
Medical Implants·1,201 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAI...
Medical Implants·9 affected·Oct 23, 2013
High RiskFDA
Carl Zeiss Meditec, Inc.
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), C...
Medical Implants·4,907 affected·Oct 23, 2013
High RiskFDA
Spinefrontier, Inc.
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization an...
Medical Implants·35 affected·Oct 18, 2013
High RiskFDA
Bausch & Lomb Surgical, Inc.
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the v...
Medical Implants·336 affected·Oct 16, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Ma...
Medical Implants·44 affected·Oct 15, 2013
High RiskFDA
Zimmer, Inc.
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
Medical Implants·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a tempo...
Medical Implants·94 affected·Oct 9, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for...
Medical Implants·548 affected·Oct 8, 2013