Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches
Biomet 3i is recalling 1,648,273 dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of LDA Screw SBL 4mm(D) dental implants (Item: SCRSBL2, Lot # 1087616). The recall was initiated because pouches containing the implants may not have been sealed during the packing process.
The affected products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. The source text does not specify any reported illnesses or injuries associated with this recall.
Consumers and healthcare providers should stop using the affected dental implants and contact Biomet 3i, LLC for further instructions on how to return or dispose of the products.
The recalled product
- Product
- LDA Screw SBL 4mm(D) Item: SCRSBL2 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)
- Lot # 1087616
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.
See all 119 products in this recall →Related recalls
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