Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
Medical Implants·22 affected·Mar 18, 2021
High RiskFDA
Howmedica Osteonics Corp.
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibia...
Medical Implants·113 affected·Mar 5, 2021
High RiskFDA
Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1...
Medical Implants·23,123 affected·Feb 26, 2021
High RiskFDA
Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 110...
Medical Implants·23,123 affected·Feb 26, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replac...
Medical Implants·102 affected·Feb 22, 2021
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access...
Medical Implants·267 affected·Feb 22, 2021
CriticalFDA
Medtronic Vascular, Inc.
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Medical Implants·33,430 affected·Feb 12, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary ...
Medical Implants·229 affected·Feb 12, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged E...
Medical Implants·59 affected·Feb 12, 2021
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Qua...
Medical Implants·238,393 affected·Feb 3, 2021
High RiskFDA
Biomerieux Inc
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test,...
Medical Implants·6,777 affected·Jan 28, 2021
High RiskFDA
Corin Ltd
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Cer...
Medical Implants·23 affected·Jan 25, 2021
High RiskFDA
Corin Ltd
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Cera...
Medical Implants·23 affected·Jan 25, 2021
High RiskFDA
Northgate Technologies, Inc.
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention me...
Medical Implants·45 affected·Jan 15, 2021
High RiskFDA
Cook Inc.
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotr...
Medical Implants·42 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Medical Implants·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Medical Implants·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Medical Implants·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Medical Implants·7,400,000 affected·Jan 4, 2021
High RiskFDA
Baxter Healthcare Corporation
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascula...
Medical Implants·109 affected·Dec 28, 2020
High RiskFDA
Smith & Nephew, Inc.
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium visc...
Medical Implants·5,190 affected·Dec 18, 2020
High RiskFDA
Depuy Orthopaedics, Inc.
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050...
Medical Implants·14,161 affected·Dec 15, 2020
High RiskFDA
Bard Peripheral Vascular Inc
VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/6...
Medical Implants·23,029 affected·Dec 14, 2020
High RiskFDA
Bard Peripheral Vascular Inc
VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/6...
Medical Implants·12,258 affected·Dec 14, 2020
High RiskFDA
Boston Scientific Corporation
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for ...
Medical Implants·78 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantati...
Medical Implants·38 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for ...
Medical Implants·61 affected·Dec 1, 2020
High RiskFDA
Biomet, Inc.
Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and inten...
Medical Implants·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, M...
Medical Implants·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180...
Medical Implants·7,428 affected·Nov 25, 2020
High RiskFDA
Medtronic Neuromodulation
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation ther...
Medical Implants·12 affected·Nov 19, 2020
CriticalFDA
Heartware, Inc.
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1...
Medical Implants·19,562 affected·Nov 19, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714...
Medical Implants·219 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714...
Medical Implants·319 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714...
Medical Implants·302 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 0871472...
Medical Implants·386 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 0871472...
Medical Implants·278 affected·Nov 17, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and...
Medical Implants·2 affected·Nov 15, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization ther...
Medical Implants·2 affected·Nov 15, 2020
CriticalFDA
Boston Scientific Corporation
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Medical Implants·47,000 affected·Nov 13, 2020
High RiskFDA
Medtronic Neuromodulation
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended fo...
Medical Implants·7,960 affected·Nov 12, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Medical Implants·3 affected·Nov 5, 2020
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidat...
Medical Implants·8,962 affected·Oct 23, 2020
High RiskFDA
Geistlich Pharma North America, Inc.
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology...
Medical Implants·537 affected·Oct 19, 2020
High RiskFDA
Merz North America, Inc.
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of ca...
Medical Implants·2,051 affected·Sep 30, 2020
RecallFDA
Advanced Bionics, Llc
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Proces...
Medical Implants·28 affected·Sep 26, 2020
RecallFDA
Advanced Bionics, Llc
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Proces...
Medical Implants·53 affected·Sep 26, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-...
Medical Implants·412 affected·Sep 24, 2020