Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
In2bones, Sas
Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.2...
Medical Implants·287 affected·Jul 13, 2017
High RiskFDA
Zimmer Dental Inc
IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; ...
Medical Implants·169 affected·Jul 10, 2017
High RiskFDA
Stanmore Implants Worldwide Ltd.
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in t...
Medical Implants·15 affected·Jul 4, 2017
High RiskFDA
Zoll Medical Corporation
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management o...
Medical Implants·46 affected·Jun 30, 2017
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended ...
Medical Implants·9,200 affected·Jun 29, 2017
High RiskFDA
Encore Medical, Lp
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone ...
Medical Implants·9,848 affected·Jun 26, 2017
High RiskFDA
Encore Medical, Lp
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for ...
Medical Implants·840 affected·Jun 26, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to dril...
Medical Implants·84 affected·Jun 26, 2017
High RiskFDA
Encore Medical, Lp
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone ...
Medical Implants·1,815 affected·Jun 26, 2017
High RiskFDA
Encore Medical, Lp
Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for ...
Medical Implants·7,143 affected·Jun 26, 2017
High RiskFDA
Keystone Dental Inc
Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully ...
Medical Implants·20 affected·Jun 20, 2017
High RiskFDA
Keystone Dental Inc
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for ...
Medical Implants·72 affected·Jun 16, 2017
High RiskFDA
Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
Medical Implants·23 affected·Jun 10, 2017
High RiskFDA
Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
Medical Implants·54 affected·Jun 10, 2017
High RiskFDA
Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Medical Implants·2 affected·Jun 10, 2017
High RiskFDA
Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Medical Implants·16 affected·Jun 10, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Prod...
Medical Implants·6,290 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 ...
Medical Implants·1,517 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide ...
Medical Implants·7,888 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Ti...
Medical Implants·10,116 affected·Jun 5, 2017
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: The Ball Ti...
Medical Implants·1,631 affected·Jun 5, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device design...
Medical Implants·40 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device desi...
Medical Implants·443 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device design...
Medical Implants·373 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator ...
Medical Implants·9,529 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device design...
Medical Implants·54 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator ...
Medical Implants·8,780 affected·Jun 2, 2017
High RiskFDA
Atrium Medical Corporation
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12...
Medical Implants·246 affected·May 25, 2017
High RiskFDA
Medical Components, Inc Dba Medcomp
6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Pro...
Medical Implants·65 affected·May 25, 2017
CriticalFDA
Flowonix Medical, Inc.
PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: F...
Medical Implants·2,204 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orth...
Medical Implants·185 affected·May 22, 2017
High RiskFDA
Exactech, Inc.
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according t...
Medical Implants·477 affected·May 22, 2017
High RiskFDA
Zimmer Gmbh
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated fo...
Medical Implants·138 affected·May 11, 2017
High RiskFDA
Arrow International Inc
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter perm...
Medical Implants·27,485 affected·May 9, 2017
High RiskFDA
Acumed Llc
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted...
Medical Implants·13,076 affected·Apr 20, 2017
CriticalFDA
Ebi Patient Care, Inc.
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or...
Medical Implants·33 affected·Apr 20, 2017
High RiskFDA
Amendia, Inc
01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 17...
Medical Implants·15 affected·Apr 6, 2017
High RiskFDA
Mentor Texas, Lp.
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Medical Implants·28 affected·Mar 27, 2017
High RiskFDA
Arthrex, Inc.
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Medical Implants·0 affected·Mar 24, 2017
High RiskFDA
Zimmer Dental Inc
Tapered SwissPlus Implant System, Model No. SPB10
Medical Implants·188 affected·Mar 20, 2017
High RiskFDA
Medtronic Neuromodulation
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The le...
Medical Implants·86,024 affected·Mar 17, 2017
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labe...
Medical Implants·5 affected·Mar 8, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-u...
Medical Implants·124 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Implants·1,236,749 affected·Mar 3, 2017
High RiskFDA
Inion Ltd.
Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the r...
Medical Implants·36 affected·Mar 1, 2017
High RiskFDA
Zimmer Biomet, Inc.
Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip ...
Medical Implants·9,867 affected·Feb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants·9,867 affected·Feb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants·9,867 affected·Feb 28, 2017