Biomet 3i Recalls Locator Abutment Dental Implants Due to Sealing Defect
Biomet 3i 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, the Virgin Islands, and numerous foreign countries.
The reason for the recall is that pouches containing the devices may not have been sealed during packing. The affected items include codes MLOA001 through MLOA006 and LOA001 through LOA006.
Consumers and healthcare providers should contact Biomet 3i, LLC for further instructions regarding the recall.
The recalled product
- Product
- Locator Abutment Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
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 (11)
- Items: MLOA001
- MLOA002
- MLOA003
- MLOA004
- MLOA005
- MLOA006
- LOA001
- LOA002
- LOA003
- LOA004
- LOA005 and LOA006.
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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