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 is recalling specific Gingihue dental implants because their pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i is recalling Preformance Temporary Cylinder Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million Bellatek Encode Healing Abutments because pouches may not have been sealed during packing.
Biomet 3i is recalling Implant EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million Straight Healing Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling certain Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Healing Abutment Dental Implants because pouches may not have been sealed during packing.
Biomet 3i is recalling certain Gingihue Post 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 Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i, LLC is recalling specific dental implant abutments because the packaging 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.
Biomet 3i, LLC is recalling Standard Abutment Pick-Up Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 dental implant devices 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.
Biomet 3i is recalling Conical EP Pick-Up 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 is recalling EP Healing Abutment dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i, LLC is recalling certain Gingihue 15 degree Pre-Angled Post Dental implants 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 certain EP Healing Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling IOL Titanium Temporary Cylinder Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling specific O-Ring Abutments for dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 temporary dental implants because their packaging pouches may not have been sealed during packing.