Biomet 3i Recalls Dental Implants Due to Potential Label Mismatch
Biomet 3i is recalling five units of LTX dental implants because a single part in the lot may not match the label due to a supplier error.
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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a potential labeling mismatch rather than a confirmed contamination or defect causing harm.
Plain-English summary
Biomet 3i, LLC is recalling five units of BIOMET 3i LTX Dental Implants, Model LTX610 (6x10mm). The affected units are labeled as sterile and are packaged in a plastic tray within a Tyvek tray within a cardboard box. The recall involves a single lot (1199571) distributed to Argentina.
The recall was initiated because a single part within the lot potentially does not match the product on the label. This discrepancy is attributed to a commingle at the firm's supplier. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers who have purchased or received these specific dental implants should stop using them and contact Biomet 3i, LLC for further instructions or a replacement.
The recalled product
- Product
- BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 5
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 (3)
- LTX610
- lot 1199571
- UDI: (01)00844868009917(17)210916(10)1199571
Distribution
Distribution scope not specified by the agency.
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