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 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 Conical Abutment Gold Standard ZR 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 DAL-RO Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Gingihue 15-degree angled post dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical 25 degree Angled Abutment 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 approximately 1.6 million non-hexed dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Provide Impression Coping dental implant devices because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Titanium Hexed Uniscrew 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 is recalling 1,648,273 dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i is recalling headless dental implant cover screws 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 Locator Replacement Housing Kits because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.
Biomet 3i, LLC is recalling Locator Abutment dental implants because 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 is recalling Locator Extra Light Angled Replacement Males because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Temporary Hexed Cylinder Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical Abutment Pick-up Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Extended Range Males 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.