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 EP Healing Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Quickbridge TM Cap Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Pick-Up Impression Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Twist Lock Coping Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
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 certain Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Extra Light Retention Males dental implant pouches because they may not have been sealed during packing.
Biomet 3i is recalling Preformance Post Dental implants because pouches may not have been sealed during packing. The recall covers 1,648,273 devices distributed worldwide.
Biomet 3i, LLC is recalling Hex Try-in Screws because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i, LLC is recalling Preformance Temporary Cylinder Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Standard Abutment Transfer 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 Provide Impression Coping dental implant devices because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million Temporary Non-Hexed Cylinder Dental Implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 IOL Abutment 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.
Biomet 3i is recalling specific Gingihue dental implants 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 is recalling Gingihue Post Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing. The recall covers 1,648,273 units distributed worldwide.
Biomet 3i is recalling Locator Extra Light Angled Replacement Males because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 Flat Implant Cover Screws 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.
Biomet 3i, LLC is recalling 1,648,273 Implant EP Twist Lock Coping 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.