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 lots of O-Ring Abutments for dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Conical 25 degree Angled Abutment Dental Implants because pouches may not have been sealed during packing.
Biomet 3i is recalling specific dental implant abutments 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 specific dental implant copings because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i, LLC is recalling Conical EP Healing Caps for dental implants 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 Preformance 15 degrees Pre-Angled Post 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 is recalling Conical EP Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Gingihue 15 degrees Pre-Angled Post dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling DAL-RO Housing, Female Assembly dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 EP Pick-Up Coping Dental implants 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, LLC is recalling IOL Distal Extension dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling specific EP Healing Abutments because pouches may not have been sealed during packing, potentially compromising sterility.
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 Gold Slotted Screw Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Light Retention Replacement Males 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, LLC is recalling Preformance Post Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Preformance Temporary Cylinder 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 Gingihue 15 Degree Pre-Angled Post 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.