Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
Biomet 3i, Llc
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Medical Implants·51 affected·May 10, 2013
High RiskFDA
Spinefrontier, Inc.
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an...
Medical Implants·61 affected·May 7, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the pall...
Medical Implants·23 affected·Apr 23, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is ind...
Medical Implants·784 affected·Apr 23, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is ind...
Medical Implants·310 affected·Apr 23, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is ind...
Medical Implants·250 affected·Apr 23, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the pall...
Medical Implants·1,357 affected·Apr 23, 2013
CriticalFDA
Cook, Inc.
Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral ...
Medical Implants·1,057 affected·Apr 18, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
Medical Implants·1 affected·Apr 18, 2013
High RiskFDA
Ziemer Usa Inc
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in ...
Medical Implants·5 affected·Apr 16, 2013
High RiskFDA
Integra Lifesciences Corporation
BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material tha...
Medical Implants·20,032 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for ...
Medical Implants·812 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGe...
Medical Implants·52 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated fo...
Medical Implants·32,446 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for th...
Medical Implants·215 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to han...
Medical Implants·15,607 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dur...
Medical Implants·21,179 affected·Mar 28, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, ...
Medical Implants·11 affected·Mar 25, 2013
High RiskFDA
Biomet U.k., Ltd.
REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instr...
Medical Implants·430 affected·Mar 20, 2013
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist duri...
Medical Implants·6,970 affected·Mar 18, 2013
High RiskFDA
Spinefrontier, Inc.
Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle scre...
Medical Implants·8 affected·Mar 14, 2013
High RiskFDA
Keystone Dental Inc
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Medical Implants·120 affected·Mar 11, 2013
High RiskFDA
Orthopedic Alliance Llc
UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onse...
Medical Implants·57 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,...
Medical Implants·459 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous co...
Medical Implants·30 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller ...
Medical Implants·50 affected·Feb 20, 2013
High RiskFDA
Orthopedic Alliance Llc
Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm C...
Medical Implants·5 affected·Feb 20, 2013
High RiskFDA
Zimmer, Inc.
Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R8...
Medical Implants·58 affected·Feb 8, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use...
Medical Implants·4 affected·Jan 24, 2013
High RiskFDA
Bard Peripheral Vascular Inc
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, ...
Medical Implants·315 affected·Jan 23, 2013
High RiskFDA
Envoy Medical Corporation
Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA an...
Medical Implants·44 affected·Jan 9, 2013
High RiskFDA
Biomet, Inc.
TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to ...
Medical Implants·44 affected·Jan 3, 2013
High RiskFDA
Heartware Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Medical Implants·3,544 affected·Dec 27, 2012
High RiskFDA
Medacta Usa Inc
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to...
Medical Implants·26 affected·Dec 17, 2012
High RiskFDA
Biomet Spine, Llc
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commerci...
Medical Implants·1,999 affected·Nov 30, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET pe...
Medical Implants·118 affected·Nov 28, 2012
High RiskFDA
Biomet, Inc.
Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for ap...
Medical Implants·200 affected·Nov 15, 2012
CriticalFDA
Medtronic Neuromodulation
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump i...
Medical Implants·174,700 affected·Nov 9, 2012
High RiskFDA
Spinefrontier, Inc.
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric...
Medical Implants·13 affected·Nov 9, 2012
CriticalFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene ox...
Medical Implants·174,700 affected·Nov 9, 2012
High RiskFDA
Depuy Spine, Inc.
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
Medical Implants·36 affected·Nov 7, 2012
High RiskFDA
Depuy Spine, Inc.
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
Medical Implants·6 affected·Nov 7, 2012
High RiskFDA
Biomet, Inc.
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are prima...
Medical Implants·4 affected·Nov 1, 2012
High RiskFDA
Titan Spine, Llc
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton ...
Medical Implants·92 affected·Oct 19, 2012
High RiskFDA
Trivascular, Inc
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distribu...
Medical Implants·41 affected·Oct 19, 2012
High RiskFDA
Ossur Americas, Inc.
The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC L...
Medical Implants·144 affected·Oct 15, 2012
High RiskFDA
Spinefrontier, Inc.
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm...
Medical Implants·11 affected·Oct 5, 2012
High RiskFDA
Biomet 3i, Llc
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for...
Medical Implants·76 affected·Sep 28, 2012