Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 91 of 125
Baxter Healthcare Corp.
Class II Terminated
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end...
Reason: Instructions for use booklet may puncture the outer Tyvek lid.
Z-1629-2016 May 18, 2016 Deerfield, IL
Applied Medical Technology Inc
Class II Terminated
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Reason: The firm received a complaint of an open pouch which breaches the sterilization validation.
Z-1611-2016 May 11, 2016 Brecksville, OH
Applied Medical Technology Inc
Class II Terminated
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue re...
Reason: The firm received a complaint of an open pouch which breaches the sterilization validation.
Z-1610-2016 May 11, 2016 Brecksville, OH
Nuvectra
Class II Terminated
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1...
Reason: If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (...
Z-1600-2016 May 11, 2016 Blaine, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class II Terminated
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring system...
Reason: A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up conf...
Z-1605-2016 May 11, 2016 Mounds View, MN
Boston Scientific Corporation
Class II Terminated
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for pal...
Reason: Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
Z-1567-2016 May 4, 2016 Marlborough, MA
Mako Surgical Corporation
Class II Terminated
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surger...
Reason: Potential disassociation of the orientation pin.
Z-1583-2016 May 4, 2016 Plantation, FL
X-NAV Technologies, LLC
Class II Terminated
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning pha...
Reason: The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patien...
Z-1391-2016 April 20, 2016 Lansdale, PA
Synthes (USA) Products LLC
Class II Terminated
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement...
Reason: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon ...
Z-1384-2016 April 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement...
Reason: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon ...
Z-1387-2016 April 20, 2016 West Chester, PA
Customed, Inc
Class II Terminated
Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1485-2016 April 20, 2016 Fajardo, PR
Synthes (USA) Products LLC
Class II Terminated
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement...
Reason: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon ...
Z-1386-2016 April 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement...
Reason: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon ...
Z-1383-2016 April 20, 2016 West Chester, PA
Arthrex, Inc.
Class II Terminated
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titan...
Reason: Potential for a component contained in the Implant System to be non-sterile.
Z-1360-2016 April 20, 2016 Naples, FL
Synthes (USA) Products LLC
Class II Terminated
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement...
Reason: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon ...
Z-1385-2016 April 20, 2016 West Chester, PA
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013...
Reason: Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level.
Z-1267-2016 April 6, 2016 Westlake Village, CA
Philips Medical Systems, Inc.
Class II Terminated
Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper ...
Reason: Loss of key image functionality due to a bent pedal of the Footswitch.
Z-1280-2016 April 6, 2016 Andover, MA
Medtronic Neuromodulation
Class II Terminated
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Reason: Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with ...
Z-1271-2016 April 6, 2016 Minneapolis, MN
Innovative Ophthalmic Products, Inc
Class II Terminated
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
Reason: Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a cau...
Z-1252-2016 April 6, 2016 Costa Mesa, CA
QiG Group LLC
Class II Terminated
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
Reason: The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as clo...
Z-1192-2016 March 30, 2016 Blaine, MN
QiG Group LLC
Class II Terminated
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
Reason: The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as clo...
Z-1193-2016 March 30, 2016 Blaine, MN
QiG Group LLC
Class II Terminated
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Reason: The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as clo...
Z-1194-2016 March 30, 2016 Blaine, MN
Arthrex, Inc.
Class II Terminated
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7...
Reason: Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.
Z-1195-2016 March 30, 2016 Naples, FL
Zimmer Manufacturing B.V.
Class II Terminated
Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 2...
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Z-1125-2016 March 23, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CR...
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Z-1102-2016 March 23, 2016 Mercedita, PR