Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 89 of 125
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric...
Reason: The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a p...
Z-2046-2016 June 29, 2016 Westlake Village, CA
Ev3, Inc.
Class II Terminated
EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nit...
Reason: Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Sy...
Z-2048-2016 June 29, 2016 Plymouth, MN
Zimmer Trabecular Metal Technology, Inc.
Class II Terminated
POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouche...
Z-1950-2016 June 22, 2016 Parsippany, NJ
Zimmer Trabecular Metal Technology, Inc.
Class II Terminated
TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 005...
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouche...
Z-1951-2016 June 22, 2016 Parsippany, NJ
Zimmer Trabecular Metal Technology, Inc.
Class II Terminated
REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 0070...
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouche...
Z-1954-2016 June 22, 2016 Parsippany, NJ
Zimmer Gmbh
Class II Terminated
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retr...
Reason: In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which r...
Z-2003-2016 June 22, 2016 Winterthur
Zimmer Trabecular Metal Technology, Inc.
Class II Terminated
TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB SZ 3 C/D, 17MM - 00588605317 TM LPS TIB SZ 4 C/D, 10MM - ...
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouche...
Z-1952-2016 June 22, 2016 Parsippany, NJ
Zimmer Trabecular Metal Technology, Inc.
Class II Terminated
00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/...
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouche...
Z-1955-2016 June 22, 2016 Parsippany, NJ
Integra LifeSciences Corp.
Class II Terminated
TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm ...
Reason: As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth...
Z-1965-2016 June 22, 2016 Plainsboro, NJ
Zimmer Trabecular Metal Technology, Inc.
Class II Terminated
TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ ...
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouche...
Z-1953-2016 June 22, 2016 Parsippany, NJ
Brainlab AG
Class II Terminated
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Reason: Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Z-1929-2016 June 15, 2016 Feldkirchen, N/A
Zimmer Biomet, Inc.
Class II Terminated
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
Reason: Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in impl...
Z-1917-2016 June 15, 2016 Warsaw, IN
Medtronic Neuromodulation
Class II Terminated
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unil...
Reason: Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery dep...
Z-1926-2016 June 15, 2016 Minneapolis, MN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1816-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1825-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1826-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1817-2016 June 1, 2016 Warsaw, IN
B. Braun Medical, Inc.
Class II Terminated
WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into imp...
Reason: Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
Z-1703-2016 June 1, 2016 Allentown, PA
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1822-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1823-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. guide, surgical, instrument
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1815-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1819-2016 June 1, 2016 Warsaw, IN
Limacorporate S.p.A
Class II Terminated
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Reason: Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Z-1711-2016 June 1, 2016 San Daniele Del Friuli, N/A
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Bit, drill.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1821-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1827-2016 June 1, 2016 Warsaw, IN