Biomet 3i Recalls Discolored OSSEOTITE Tapered Dental Implants
Biomet 3i is recalling 620 OSSEOTITE 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 hazard is limited to cosmetic discoloration caused by machine fluid, with no reported injuries or illnesses.
Plain-English summary
Biomet 3i, LLC is recalling 620 units of OSSEOTITE Tapered Certain Implants. The affected implants are prescription-only dental implants with a size of 3.25 x 18.5 - 15.0 mm. The specific product code is Implant PN # IFNT3211, Lot # 2014051477, with an expiration date of 12/06/2018.
The recall was initiated because the endosseous dental implants came into contact with a residual machine fluid, which caused the implants to become discolored. The agency has classified this recall as Class II.
The affected implants were distributed worldwide, including nationwide distribution in the United States and in several international countries. Consumers and healthcare providers should stop using the affected implants and contact Biomet 3i, LLC for further instructions.
The recalled product
- Product
- OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 620
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)
- Implant PN # IFNT3211 Lot # 2014051477 Exp date 12/06/2018
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Biomet 3i, LLC
See all →- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- HighBiomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls Misaligned BellaTek Dental Abutments
FDA (Devices) · 2020-10-14
Same hazard · discoloration
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
Similar recalls
- SevereBiomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth
FDA (Devices) · 2012-11-28
- HighBiomet 3i Recalls Dental Implants Due to Missing Internal Threading
FDA (Devices) · 2012-10-31
- HighBiomet 3i Recalls Dental Implants Due to Residual Machining Fluid
FDA (Devices) · 2014-04-23
- HighBiomet 3i Recalls Dental Implants Due to Missing Internal Thread
FDA (Devices) · 2012-06-27
- LowBiomet 3i Recalls 92 Dental Implants Due to Packaging Error
FDA (Devices) · 2016-09-28
- HighBiomet 3i Recalls Dental Implants Due to Shallow Internal Hex Depth
FDA (Devices) · 2012-08-15