Biomet 3i Recalls Locator Abutment Dental Implants Due to Sealing Issues
Biomet 3i, LLC is recalling Locator Abutment 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 Locator Abutment dental implants. The recall involves 1,648,273 devices distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands.
The recall was initiated because pouches containing the devices may not have been sealed during packing. This packaging defect could potentially compromise the sterility or integrity of the dental implants.
Dental professionals and patients who have received these specific Locator Abutment dental implants should contact Biomet 3i, LLC for further instructions on how to proceed.
The recalled product
- Product
- Certain Locator Abutment 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 (12)
- Items: IMLOA001
- IMLOA002
- IMLOA003
- IMLOA004
- IMLOA005
- IMLOA006
- ILOA001
- ILOA002
- ILOA003
- ILOA004
- ILOA005
- and ILOA006.
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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