Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
Cordis Corporation
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal a...
Medical Implants·120 affected·Dec 22, 2014
High RiskFDA
Stryker Craniomaxillofacial Division
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bear...
Medical Implants·1,051 affected·Dec 17, 2014
High RiskFDA
Stryker Craniomaxillofacial Division
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for no...
Medical Implants·1,051 affected·Dec 17, 2014
High RiskFDA
Stryker Craniomaxillofacial Division
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implan...
Medical Implants·1,051 affected·Dec 17, 2014
High RiskFDA
Zimmer, Inc.
Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Pro...
Medical Implants·67,963 affected·Dec 11, 2014
High RiskFDA
Mentor Texas, Lp.
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Medical Implants·45 affected·Dec 11, 2014
High RiskFDA
Zimmer, Inc.
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Medical Implants·40 affected·Dec 8, 2014
High RiskFDA
Ev3, Inc.
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high r...
Medical Implants·24 affected·Dec 4, 2014
High RiskFDA
Zimmer, Inc.
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable ...
Medical Implants·83 affected·Dec 4, 2014
High RiskFDA
Ev3, Inc.
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high r...
Medical Implants·14 affected·Dec 4, 2014
High RiskFDA
Biomet, Inc.
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemente...
Medical Implants·9 affected·Dec 2, 2014
High RiskFDA
Arthrosurface, Inc.
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Arti...
Medical Implants·143 affected·Nov 24, 2014
High RiskFDA
Arthrosurface, Inc.
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Ar...
Medical Implants·187 affected·Nov 24, 2014
High RiskFDA
Arthrosurface, Inc.
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articul...
Medical Implants·138 affected·Nov 24, 2014
High RiskFDA
Arthrosurface, Inc.
Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articu...
Medical Implants·182 affected·Nov 24, 2014
High RiskFDA
Arthrosurface, Inc.
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Artic...
Medical Implants·136 affected·Nov 24, 2014
High RiskFDA
Biomet 3i, Llc
OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
Medical Implants·620 affected·Nov 7, 2014
High RiskFDA
Biomet 3i, Llc
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Medical Implants·620 affected·Nov 7, 2014
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Medical Implants·45 affected·Nov 4, 2014
High RiskFDA
Zimmer Cas
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is ...
Medical Implants·15 affected·Nov 3, 2014
High RiskFDA
Straumann Usa, Llc
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
Medical Implants·362 affected·Oct 27, 2014
High RiskFDA
Medacta Usa
The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Medical Implants·32 affected·Oct 21, 2014
High RiskFDA
Skeletal Dynamics
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pa...
Medical Implants·1,700 affected·Oct 16, 2014
High RiskFDA
American Medical Systems, Inc.
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The A...
Medical Implants·10,085 affected·Oct 15, 2014
High RiskFDA
American Medical Systems, Inc.
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 724041...
Medical Implants·2,165 affected·Oct 15, 2014
High RiskFDA
American Medical Systems, Inc.
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 70...
Medical Implants·184 affected·Oct 10, 2014
High RiskFDA
Ebi, Llc
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also availa...
Medical Implants·2,816 affected·Oct 8, 2014
High RiskFDA
Mako Surgical Corporation
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the p...
Medical Implants·404 affected·Oct 7, 2014
High RiskFDA
Mako Surgical Corporation
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically...
Medical Implants·404 affected·Oct 7, 2014
High RiskFDA
Zimmer, Inc.
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedur...
Medical Implants·618 affected·Oct 7, 2014
High RiskFDA
Zimmer, Inc.
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Medical Implants·352 affected·Oct 2, 2014
High RiskFDA
Zimmer Dental Inc
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X...
Medical Implants·1,044 affected·Oct 1, 2014
High RiskFDA
4-web Inc.
ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-L...
Medical Implants·35 affected·Sep 29, 2014
CriticalFDA
Trivascular, Inc
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System...
Medical Implants·0 affected·Sep 20, 2014
High RiskFDA
Orthohelix Surgical Designs Inc
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during p...
Medical Implants·38 affected·Sep 19, 2014
High RiskFDA
Boston Scientific Crm Corp
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models ...
Medical Implants·31,144 affected·Sep 17, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made i...
Medical Implants·1,147 affected·Aug 15, 2014
High RiskFDA
Instradent Usa, Inc.
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for ...
Medical Implants·13 affected·Aug 11, 2014
High RiskFDA
Orthopediatrics Corp
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reco...
Medical Implants·56 affected·Jul 25, 2014
High RiskFDA
Zimmer, Inc.
Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20...
Medical Implants·972,125 affected·Jul 22, 2014
High RiskFDA
Vascutek, Ltd.
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Medical Implants·63,162 affected·Jul 15, 2014
High RiskFDA
Medtronic Neuromodulation
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. ...
Medical Implants·1,200 affected·Jul 11, 2014
High RiskFDA
Innovasis, Inc
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed pla...
Medical Implants·32 affected·Jul 7, 2014
High RiskFDA
Stryker Spine
Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion int...
Medical Implants·64 affected·Jul 7, 2014
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implant...
Medical Implants·9,498 affected·Jul 3, 2014
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides...
Medical Implants·9,498 affected·Jul 3, 2014
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmab...
Medical Implants·9,498 affected·Jul 3, 2014
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman...
Medical Implants·9,498 affected·Jul 3, 2014