Biomet 3i Recalls Dental Implants Due to Residual Machining Fluid
Biomet 3i is recalling 34,744 endosseous dental implants because residual machining fluid was identified on the external surface.
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 medical device with a potential contamination hazard (residual machining fluid) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biomet 3i, LLC is recalling 34,744 BIOMET 3i Endosseous Dental Implants. The recall was initiated because residual machining fluid was identified on the external surface of the dental implants, which appeared darker in color than expected.
The affected devices were manufactured between November 5, 2012, and August 21, 2013. These implants were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, Germany, and Japan.
Consumers and healthcare providers should contact Biomet 3i for instructions on how to return the affected devices. The specific model numbers affected are listed in the official recall documentation.
The recalled product
- Product
- BIOMET 3i Endosseous Dental Implant.
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implant
- Affected units
- 34,744
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 (20)
- Model Number(s): Affected devices catalog names are: BNES310
- BNET3210
- BNPS6511
- BNPS6513
- BNPS6585
- BNPT6510
- BNPT6511
- BNPT6513
- BNPT6585
- BNSS310
- BNSS311
- BNSS313
- BNSS610
- BNSS613
- BNSS615
- BNSS685
- BNST3210
- BNST3211
- BNST3213
- BNST3215
Distribution
Distribution scope not specified by the agency.
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