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 1.6 million Temporary Non-Hexed Cylinder Dental Implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million dental implant protection caps 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, LLC is recalling 1,648,273 Conical Healing Caps for dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling IOL Pick-Up Impression Coping dental implant devices because pouches may not have been sealed during packing.
Biomet 3i is recalling IOL Abutment and Screw dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical 17 degree Angled Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 LDA Screw SBL 3mm(D) dental implants 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 is recalling specific dental implant abutments because their packaging pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 titanium dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Implant Twist Lock TM Coping 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 IOL Transfer Impression Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Preformance 15 degrees pre-angled post 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 1.6 million dental implant abutments because some 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 Gold-Tite Square Uniscrew dental implants because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.
Biomet 3i, LLC is recalling Locator Replacement Males 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 1,648,273 Temporary Healing Retention Cylinders 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.