Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
Keystone Dental Inc
Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artif...
Medical Implants·13 affected·Feb 22, 2019
High RiskFDA
Keystone Dental Inc
Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as...
Medical Implants·1 affected·Feb 22, 2019
High RiskFDA
Bard Peripheral Vascular Inc
LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP ...
Medical Implants·127 affected·Feb 18, 2019
High RiskFDA
Acell, Inc
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended ...
Medical Implants·1 affected·Feb 14, 2019
High RiskFDA
Acell, Inc
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended ...
Medical Implants·1 affected·Feb 14, 2019
High RiskFDA
Matrix Surgical Holdings, Llc
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes ar...
Medical Implants·46 affected·Jan 30, 2019
High RiskFDA
Matrix Surgical Holdings, Llc
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes ar...
Medical Implants·42 affected·Jan 30, 2019
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model...
Medical Implants·7,469 affected·Jan 17, 2019
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR...
Medical Implants·9,915 affected·Jan 17, 2019
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-se...
Medical Implants·47,086 affected·Jan 17, 2019
High RiskFDA
Miami Device Solutions, Llc.
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, a...
Medical Implants·15 affected·Jan 15, 2019
High RiskFDA
Aap Implantate Ag
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of b...
Medical Implants·25 affected·Jan 11, 2019
High RiskFDA
Ottobock Orthopedic Industrie
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. Th...
Medical Implants·110 affected·Jan 10, 2019
High RiskFDA
Ottobock Orthopedic Industrie
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees....
Medical Implants·538 affected·Jan 10, 2019
High RiskFDA
Acuity Surgical Devices, Llc
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Op...
Medical Implants·27 affected·Jan 7, 2019
High RiskFDA
Acuity Surgical Devices, Llc
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-...
Medical Implants·27 affected·Jan 7, 2019
High RiskFDA
Cook Inc.
Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 ...
Medical Implants·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
Medical Implants·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
Medical Implants·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
Medical Implants·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
Medical Implants·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 ...
Medical Implants·13,388 affected·Jan 4, 2019
High RiskFDA
Boston Scientific Corporation
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Medical Implants·18 affected·Dec 26, 2018
High RiskFDA
Brosmed Medical Co.,ltd.
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofe...
Medical Implants·400 affected·Dec 14, 2018
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 ...
Medical Implants·11 affected·Dec 7, 2018
High RiskFDA
Exactech, Inc.
Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals...
Medical Implants·40 affected·Dec 5, 2018
High RiskFDA
Conformis, Inc.
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Pro...
Medical Implants·2 affected·Dec 3, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Im...
Medical Implants·232 affected·Nov 28, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Im...
Medical Implants·274 affected·Nov 28, 2018
High RiskFDA
Howmedica Osteonics Corp.
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLI...
Medical Implants·28,461 affected·Nov 28, 2018
High RiskFDA
Zimmer Biomet, Inc.
Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments ...
Medical Implants·971 affected·Nov 28, 2018
RecallFDA
Ascension Orthopedics, Inc
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Medical Implants·0 affected·Nov 16, 2018
High RiskFDA
Livanova Usa Inc
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte...
Medical Implants·9,282 affected·Nov 16, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Den...
Medical Implants·53 affected·Oct 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. C...
Medical Implants·6 affected·Oct 24, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A...
Medical Implants·2,080 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Prod...
Medical Implants·780 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgi...
Medical Implants·48,320 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A...
Medical Implants·9,387 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A sing...
Medical Implants·3,764 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A singl...
Medical Implants·2,519 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product U...
Medical Implants·4,122 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product...
Medical Implants·1,676 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical ...
Medical Implants·8,027 affected·Oct 22, 2018
High RiskFDA
Richard Wolf Gmbh
Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscope...
Medical Implants·873 affected·Oct 17, 2018
High RiskFDA
Med-el Elektromedizinische Gereate, Gmbh
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; ...
Medical Implants·7 affected·Oct 16, 2018
High RiskFDA
St. Jude Medical, Inc.
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Pl...
Medical Implants·0 affected·Oct 11, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018