Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 84 of 125
Biomet 3i, LLC
Class II Terminated
Certain Conical 17 degree Angled Abutment Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2513-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Conical EP Pick-Up Coping (Hexed) Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2453-2016 August 24, 2016 Palm Beach Gardens, FL
Stanmore Implants Worldwide Ltd.
Class II Terminated
METS SMILES Total Knee Replacement
Reason: The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee componen...
Z-2553-2016 August 24, 2016 Borehamwood, N/A
Biomet 3i, LLC
Class II Terminated
Certain Straight Healing Abutment Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2496-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Locator Replacement Housing Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2431-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2414-2016 August 24, 2016 Palm Beach Gardens, FL
TYRX Inc.
Class II Terminated
TRYX Antibacterial Envelope Rx Only 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-2539-2016 August 24, 2016 Monmouth Junction, NJ
Biomet 3i, LLC
Class II Terminated
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2406-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Locator Light Retention Replacement Males 4pk Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2430-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Preformance 15 degrees pre-angled post Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2435-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Gold Slotted Screw Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2466-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2426-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2420-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Non-Hexed Implant Pick-up Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2489-2016 August 24, 2016 Palm Beach Gardens, FL
Reshape Medical Inc
Class II Terminated
ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with d...
Reason: Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly...
Z-2552-2016 August 24, 2016 San Clemente, CA
Biomet 3i, LLC
Class II Terminated
Provide Protection Cap Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2441-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Conical 25 degree Angled Abutment Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2505-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Titanium Large Hexed Screw Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2500-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Pick-Up Impression Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2434-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Conical Abutment Gold Standard ZR TM Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2507-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
EP Healing Abutment Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2463-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2409-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Gingihue 15 Degree Pre-Angled Post Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2464-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Preformance Post Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2492-2016 August 24, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2410-2016 August 24, 2016 Palm Beach Gardens, FL