Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches
Biomet 3i, LLC is recalling Standard Abutment Transfer Coping Dental implants because pouches may not have been sealed during packing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a packaging issue (unsealed pouches) with no reported injuries or illnesses, fitting the criteria for a low-severity packaging-only problem.
Plain-English summary
Biomet 3i, LLC is recalling Standard Abutment Transfer Coping Dental implants. The recall involves 1,648,273 devices distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
The reason for the recall is that pouches may not have been sealed during packing. This packaging defect could potentially compromise the sterility or integrity of the devices.
Consumers and healthcare providers should stop using these devices and contact Biomet 3i, LLC for further instructions on how to return or replace the affected products.
The recalled product
- Product
- Standard Abutment Transfer Coping Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 1,648,273
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item: SIC70
Distribution
Part of a larger recall action
This product is one of 119 recalled by Biomet 3i, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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