Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 87 of 125
Biomet 3i, LLC
Class II Terminated
Certain Twist Lock TM Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2501-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Twist Lock TM Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2503-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
IOL Pick-Up Impression Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2477-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Temporary Non-Hexed Cylinder Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2499-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2417-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
IOL Abutment and Screw Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2474-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Implant Twist Lock TM Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2472-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2418-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Standard Abutment Temporary Screw Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2445-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Locator Abutment Impression Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2481-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
DAL-RO Abutment Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2460-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Conical 17 degree Angled Abutment Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2504-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain IOL Abutment Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2486-2016 August 24, 2016 Palm Beach Gardens, FL
TYRX Inc.
Class II Terminated
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Reason: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Z-2541-2016 August 24, 2016 Monmouth Junction, NJ
Biomet 3i, LLC
Class II Terminated
Bellatek Encode Healing Abutment Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2510-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Locator Extended Range Males 4pk Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2427-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Implant EP Twist Lock TM Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2471-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Temporary Hexed Cylinder Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2448-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain EP Healing Abutment Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2517-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Preformance Temporary Cylinder Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2437-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain EP Twist Lock TM Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2511-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Flat Implant Cover Screw Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2520-2016 August 24, 2016 Palm Beach Gardens, FL
Nobel Biocare Usa Llc
Class II Terminated
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelPara...
Reason: Incorrect drill protocol in the Instructions for Use (IFU)
Z-2375-2016 August 17, 2016 Yorba Linda, CA
Zimmer Biomet Spine, Inc
Class II Terminated
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Reason: Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the imp...
Z-2398-2016 August 17, 2016 Broomfield, CO
Stryker Howmedica Osteonics Corp.
Class II Terminated
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, ...
Reason: It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assem...
Z-2390-2016 August 17, 2016 Mahwah, NJ