Biomet 3i Recalls T3 Dental Implants Due to Machine Fluid Discoloration
Biomet 3i, LLC is recalling 620 T3 Non-Platform Switched Tapered Dental Implants because contact with residual machine fluid caused discoloration.
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 defect is cosmetic (discoloration) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is voluntarily recalling 620 units of 3i T3 Non-Platform Switched Tapered Implant Rx Only dental implants. The affected products are identified by Part Number BOST3211 and include Lot # 2014051395 (Expiration 12/11/2018) and Lot # 2014051817 (Expiration 12/09/2018). The implants are available in sizes ranging from 3.25 x 8.5 mm to 3.25 x 15.0 mm.
The recall was initiated because the endosseous dental implants came into contact with a residual machine fluid, which resulted in the implants being discolored. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected implants were distributed worldwide, including nationwide in the United States and in specific countries such as Austria, Australia, Canada, France, Germany, Italy, Japan, the Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and the United Kingdom. Healthcare providers and patients who have these specific implants should contact Biomet 3i, LLC for further instructions regarding the recall.
The recalled product
- Product
- 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 620
Distribution
Part of a larger recall action
This product is one of 3 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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