FDA (Devices) recall action 73184
The FDA (Devices) publishes a recall like this one as 119 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 119 pages.
Pouches may not have been sealed during packing.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Biomet 3i, LLC is recalling Temporary Hexed Cylinder Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Replacement Housing Kits because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.
Biomet 3i is recalling Implant EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Prep-tite Cap Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling IOL Distal Extension dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Conical Healing Caps for dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Twist Lock Straight Transfer Coping Dental Implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Prep-Tite Post Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Conical 25 degree Angled Abutment Dental Implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical Abutment Gold Standard ZR Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling DAL-RO Threaded Female Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical 17 degree Angled Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 Temporary Healing Retention Cylinders because pouches may not have been sealed during packing.
Biomet 3i is recalling specific dental implants because their pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i, LLC is recalling Conical EP Healing Caps for dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 LDA Screw SBL 3mm(D) dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling DAL-RO Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million conical abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Provide Abutment Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Gold-Tite Square Uniscrew dental implants because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.
Biomet 3i is recalling Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i, LLC is recalling Conical 25 degree Angled Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Temporary Hexed Cylinder Dental implants because pouches may not have been sealed during packing.