Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Medical Implants·2 affected·Apr 16, 2018
High RiskFDA
Spinal Elements
AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Dev...
Medical Implants·19 affected·Apr 16, 2018
High RiskFDA
Cardiovascular Systems Inc
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Us...
Medical Implants·18 affected·Apr 13, 2018
High RiskFDA
Bard Brachytherapy, Inc.
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-...
Medical Implants·70 affected·Apr 10, 2018
High RiskFDA
Covidien Llc
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN ...
Medical Implants·5,547 affected·Apr 9, 2018
CriticalFDA
Abbott
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-te...
Medical Implants·5,607 affected·Apr 5, 2018
High RiskFDA
Zimmer Biomet, Inc.
Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device ...
Medical Implants·30 affected·Apr 2, 2018
High RiskFDA
Nobel Biocare Usa Llc
Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and low...
Medical Implants·74 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product...
Medical Implants·682 affected·Mar 14, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap s...
Medical Implants·298 affected·Mar 14, 2018
High RiskFDA
Keystone Dental Inc
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into a...
Medical Implants·19 affected·Mar 13, 2018
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) ...
Medical Implants·231 affected·Mar 13, 2018
High RiskFDA
Southern Implants, (pty.) Ltd.
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to ...
Medical Implants·49 affected·Mar 8, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced N...
Medical Implants·24 affected·Mar 1, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset ...
Medical Implants·12 affected·Mar 1, 2018
High RiskFDA
Biomet, Inc.
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reco...
Medical Implants·634 affected·Feb 28, 2018
CriticalFDA
Zimmer Biomet, Inc.
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of lon...
Medical Implants·4,879 affected·Feb 19, 2018
CriticalFDA
Zimmer Biomet, Inc.
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal...
Medical Implants·4,879 affected·Feb 19, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom...
Medical Implants·10 affected·Feb 8, 2018
High RiskFDA
Encore Medical, Lp
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical ...
Medical Implants·387 affected·Jan 30, 2018
High RiskFDA
Stryker Corporation
CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Spor...
Medical Implants·155 affected·Jan 25, 2018
High RiskFDA
Zimmer Biomet, Inc.
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Medical Implants·9 affected·Jan 24, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Medical Implants·55 affected·Jan 23, 2018
High RiskFDA
Sie Ag, Surgical Instrument Engineering
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intend...
Medical Implants·125 affected·Jan 21, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
SwishPlus Implant Intended for use in support for fixed bridgework.
Medical Implants·1,117 affected·Jan 19, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
SwishTapered Implant Intended for use in support for fixed bridgework.
Medical Implants·1,117 affected·Jan 19, 2018
High RiskFDA
Howmedica Osteonics Corp.
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthr...
Medical Implants·6 affected·Jan 12, 2018
CriticalFDA
Philips Electronics North America Corporation
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper s...
Medical Implants·705 affected·Jan 4, 2018
High RiskFDA
Implantcast Gmbh
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Si...
Medical Implants·304 affected·Dec 28, 2017
High RiskFDA
Merit Medical Systems, Inc.
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialy...
Medical Implants·0 affected·Dec 20, 2017
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd fo...
Medical Implants·1,486 affected·Dec 20, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1)...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Eve...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: ...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No...
Medical Implants·951 affected·Dec 19, 2017
High RiskFDA
Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X2...
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR Prosthesis, Hip, Semi-Constr...
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMP...
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
Medical Implants·13,227 affected·Nov 29, 2017