Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
Envoy Medical Corporation
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable M...
Medical Implants·4 affected·Jun 28, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Inter...
Medical Implants·95 affected·Jun 25, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronizati...
Medical Implants·1,842 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchron...
Medical Implants·3,560 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchron...
Medical Implants·6,712 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153...
Medical Implants·103 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide v...
Medical Implants·1,867 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D15...
Medical Implants·8,821 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154...
Medical Implants·8,890 affected·Jun 21, 2018
High RiskFDA
Inspire Medical Systems Inc.
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The d...
Medical Implants·93 affected·Jun 12, 2018
High RiskFDA
Philips Healthcare
Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and mini...
Medical Implants·459 affected·Jun 11, 2018
High RiskFDA
Zimmer Biomet, Inc.
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Medical Implants·12 affected·Jun 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
Medical Implants·12 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE...
Medical Implants·11,585 affected·Jun 5, 2018
High RiskFDA
Nakanishi Inc.
Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typ...
Medical Implants·12 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Ty...
Medical Implants·18 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are int...
Medical Implants·1,662 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are i...
Medical Implants·440 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are int...
Medical Implants·2,419 affected·Jun 1, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
Medical Implants·510 affected·May 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
Medical Implants·96 affected·May 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
Medical Implants·294 affected·May 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00
Medical Implants·665 affected·May 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00
Medical Implants·138 affected·May 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
Medical Implants·227 affected·May 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00
Medical Implants·84 affected·May 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
Medical Implants·1,024 affected·May 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00
Medical Implants·58 affected·May 30, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00
Medical Implants·182 affected·May 30, 2018
High RiskFDA
Medtronic Neuromodulation
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vect...
Medical Implants·10,800 affected·May 25, 2018
High RiskFDA
Medtronic Neuromodulation
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A2...
Medical Implants·8,182 affected·May 25, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 2...
Medical Implants·16 affected·May 18, 2018
High RiskFDA
Zimmer Biomet, Inc.
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedull...
Medical Implants·832 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implant...
Medical Implants·11 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramed...
Medical Implants·2,396 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intrame...
Medical Implants·1,234 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedull...
Medical Implants·248 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intr...
Medical Implants·449 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intrame...
Medical Implants·34 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramed...
Medical Implants·2,168 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intrame...
Medical Implants·10 affected·May 16, 2018
High RiskFDA
Encore Medical, Lp
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee sy...
Medical Implants·12 affected·May 14, 2018
High RiskFDA
Zimmer Dental Inc
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Impla...
Medical Implants·299 affected·May 10, 2018
High RiskFDA
Keystone Dental Inc
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous...
Medical Implants·72 affected·May 1, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LX...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Medical Implants·1 affected·Apr 16, 2018