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 1,648,273 titanium dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Conical Abutment Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i is recalling 1.6 million Bellatek Encode Healing Abutments because pouches may not have been sealed during packing.
Biomet 3i is recalling specific Gingihue 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 is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Locator Abutment Impression Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 dental implant cover screws 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, LLC is recalling certain Bellatek Encode Healing Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling specific dental implant copings because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i is recalling IOL Transfer Impression Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Titanium Square Uniscrew Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling IOL Pick-Up Impression Coping dental implant devices because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling IOL Abutment and Screw dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Micromini Flat Implant Cover Screws 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, LLC is recalling dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Pick-up Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling headless dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million dental implant abutments because some pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling IOL Healing Cap dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Standard Abutment Temporary Screws because pouches may not have been sealed during packing.
Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing.