Biomet 3i Recalls Titanium Square Uniscrew Dental Implants for Sealing Issues
Biomet 3i, LLC is recalling 1,648,273 Titanium Square Uniscrew 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, and the hazard involves a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 Titanium Square Uniscrew Dental implants. The recall was initiated because the product pouches may not have been sealed during the packing process.
The affected devices were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign consignees. The specific item code for the recalled products is UNIST.
Consumers and healthcare providers should stop using these specific dental implants and contact Biomet 3i, LLC for further instructions on how to proceed.
The recalled product
- Product
- Titanium Square Uniscrew 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: UNIST
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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