Biomet 3i Recalls Titanium Hexed Uniscrew Dental Implants Due to Sealing Defects
Biomet 3i, LLC is recalling 1,648,273 Titanium Hexed Uniscrew Dental implants because pouches may not have been sealed during packing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 units of Titanium Hexed 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 (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. The specific item code for the recalled product is UNIHT.
Consumers and healthcare providers should stop using the affected implants and contact Biomet 3i, LLC for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- Titanium Hexed 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: UNIHT
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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