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 dental implant abutments 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 Extended Range Males dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 Pick-Up Coping 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 is recalling specific dental implant abutments because their packaging 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 is recalling O-Ring Abutments for dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Gold Slotted Screw Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling certain Gingihue Post Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling certain EP Healing Abutment 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 Locator Abutment 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 is recalling Preformance 15 degrees Pre-Angled Post Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling certain Gingihue 15 degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Locator Replacement Males dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Preformance Post 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.