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 Pick-Up Coping dental implants because pouches may not have been sealed during packing.
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 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, LLC is recalling Index Coping Surgical Dental implants 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, LLC is recalling 1,648,273 dental implant cover screws 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 Twist Lock Coping Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i is recalling 1.6 million conical abutment 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 1,648,273 Implant EP Twist Lock Coping 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, LLC is recalling 1,648,273 Provide Abutment Dental implants because pouches 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 is recalling Locator Extra Light Retention Males dental implant pouches because they 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.
Biomet 3i, LLC is recalling Standard Abutment Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Locator Replacement Housing dental implants because pouches may not have been sealed during packing.