Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
Bard Peripheral Vascular Inc
1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, ...
Medical Implants·824 affected·Oct 1, 2019
High RiskFDA
Nobel Biocare Usa Llc
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Pr...
Medical Implants·228 affected·Aug 28, 2019
High RiskFDA
Zimmer Biomet, Inc.
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to fac...
Medical Implants·1,729 affected·Aug 21, 2019
High RiskFDA
Boston Scientific Corporation
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Medical Implants·404 affected·Aug 21, 2019
High RiskFDA
Aziyo Biologics
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (...
Medical Implants·1,018 affected·Aug 21, 2019
High RiskFDA
Boston Scientific Corporation
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Medical Implants·28 affected·Aug 21, 2019
High RiskFDA
Aziyo Biologics
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single ...
Medical Implants·2,693 affected·Aug 21, 2019
High RiskFDA
Orthopediatrics Corp
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic impl...
Medical Implants·969 affected·Aug 19, 2019
High RiskFDA
Orthopediatrics Corp
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic impla...
Medical Implants·211 affected·Aug 19, 2019
High RiskFDA
Nobel Biocare Usa Llc
Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - P...
Medical Implants·227 affected·Aug 9, 2019
High RiskFDA
Nobel Biocare Usa Llc
Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 ...
Medical Implants·239 affected·Aug 9, 2019
High RiskFDA
Nobel Biocare Usa Llc
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-...
Medical Implants·238 affected·Aug 9, 2019
High RiskFDA
Nobel Biocare Usa Llc
Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catal...
Medical Implants·478 affected·Aug 9, 2019
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Impl...
Medical Implants·23 affected·Aug 9, 2019
CriticalFDA
Allergan Plc
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-36...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Inf...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Pr...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: B...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require perio...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:1...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set S...
Medical Implants·4,026,287 affected·Jul 24, 2019
High RiskFDA
Omnilife Science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H...
Medical Implants·22 affected·Jul 23, 2019
High RiskFDA
Omnilife Science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Produ...
Medical Implants·6 affected·Jul 23, 2019
High RiskFDA
Nobel Biocare Usa Llc
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Medical Implants·221 affected·Jul 19, 2019
High RiskFDA
Voco Gmbh
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities...
Medical Implants·5 affected·Jul 9, 2019
CriticalFDA
St Jude Medical Inc.
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Medical Implants·47 affected·Jun 20, 2019
CriticalFDA
St Jude Medical Inc.
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Medical Implants·21 affected·Jun 20, 2019
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Medical Implants·167 affected·May 30, 2019
High RiskFDA
Zimmer Biomet, Inc.
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitat...
Medical Implants·3,022 affected·May 28, 2019
High RiskFDA
Zimmer Biomet, Inc.
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate...
Medical Implants·3,022 affected·May 28, 2019
High RiskFDA
Zimmer Biomet, Inc.
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantatio...
Medical Implants·3,022 affected·May 28, 2019
High RiskFDA
Medtronic Inc
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitr...
Medical Implants·1 affected·May 21, 2019
High RiskFDA
Medtronic Inc
Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral val...
Medical Implants·1 affected·May 21, 2019
High RiskFDA
I.t.s. Gmbh
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until b...
Medical Implants·65 affected·May 9, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) H...
Medical Implants·19 affected·Apr 24, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the perc...
Medical Implants·41 affected·Apr 24, 2019
High RiskFDA
Cook Inc.
Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 0...
Medical Implants·12,968 affected·Apr 22, 2019
High RiskFDA
Cook Inc.
Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040...
Medical Implants·3,711 affected·Apr 22, 2019
High RiskFDA
Omnilife Science Inc.
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument ...
Medical Implants·9 affected·Apr 12, 2019
High RiskFDA
Uromedica Inc.
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through wh...
Medical Implants·11 affected·Apr 10, 2019
High RiskFDA
Depuy Spine, Inc.
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 ...
Medical Implants·3,166 affected·Apr 8, 2019
RecallFDA
Advanced Bionics, Llc
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Su...
Medical Implants·364 affected·Apr 4, 2019
High RiskFDA
Thommen Medical Ag
Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece,...
Medical Implants·15 affected·Apr 3, 2019
High RiskFDA
Thoratec Corp.
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Medical Implants·7,200 affected·Mar 30, 2019
High RiskFDA
Ideal Implant Incorporated
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc...
Medical Implants·1,704 affected·Mar 18, 2019