Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 93 of 125
Zimmer Manufacturing B.V.
Class II Terminated
Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M Product Usage: A smooth or threaded metallic bone fixation fastener i...
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-1111-2016 March 23, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 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-1134-2016 March 23, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 1...
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-1129-2016 March 23, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a...
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-1099-2016 March 23, 2016 Mercedita, PR
Biomet, Inc.
Class II Terminated
Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly d...
Reason: Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) supplied by Kirkstall Precision was made according to the W1.4034 (420 stainles...
Z-1093-2016 March 16, 2016 Warsaw, IN
Philips Electronics North America Corporation
Class II Terminated
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including...
Reason: Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
Z-1066-2016 March 16, 2016 Andover, MA
Abbott Vascular
Class I Terminated
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product n...
Reason: Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the...
Z-0911-2016 March 16, 2016 Temecula, CA
Aesculap, Inc.
Class II Terminated
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
Reason: Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is...
Z-1043-2016 March 9, 2016 Center Valley, PA
Zimmer Biomet, Inc.
Class II Terminated
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This devic...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0831-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability d...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0842-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, ceme...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0835-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0845-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes "" This device is indicated for ...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0841-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling kn...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0836-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and ...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0844-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthr...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0837-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various s...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0840-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Canc...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0839-2016 March 2, 2016 Warsaw, IN
Stryker Spine
Class II Terminated
AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#9003...
Reason: There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Z-0852-2016 March 2, 2016 Allendale, NJ
Zimmer Biomet, Inc.
Class II Terminated
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and d...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0843-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacem...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0849-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, ...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0846-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0833-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, po...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0838-2016 March 2, 2016 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, ...
Reason: LDPE bag containing the implant adheres to the highly polished implant surface.
Z-0848-2016 March 2, 2016 Warsaw, IN