Biomet 3i Recalls Certain IOL Abutment Dental Implants Due to Sealing Issues
Biomet 3i, LLC is recalling 1,648,273 IOL Abutment Dental implants because pouches may not have been sealed during packing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries, fitting the Moderate criteria.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Certain IOL Abutment Dental implants. The recall involves items IIOL55S and IIOL70S. The devices were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
The recall was initiated because pouches may not have been sealed during packing. This packaging defect could potentially compromise the sterility or integrity of the dental implants.
Consumers and healthcare providers should stop using these specific dental implants and contact Biomet 3i, LLC for further instructions or a replacement.
The recalled product
- Product
- Certain IOL Abutment Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- 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)
- Items: IIOL55S and IIOL70S
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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