Biomet 3i Recalls Discolored OSSEOTITE Dental Implants
Biomet 3i is recalling 620 OSSEOTITE dental implants that were discolored due to contact with residual machine fluid.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the defect is limited to discoloration caused by machine fluid contact. The source text does not report any injuries, illnesses, or functional failures, fitting the criteria for a low-severity cosmetic or packaging-related issue.
Plain-English summary
Biomet 3i, LLC is recalling 620 OSSEOTITE Certain 2 Dental Implants (3.25 x 8.5 - 18 mm). The recall involves a specific lot (Lot # 2014051368) with an expiration date of 12/03/2018. The implants were distributed nationwide in the United States and in several international countries, including Austria, Australia, Canada, France, Germany, Italy, Japan, the Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and the United Kingdom.
The reason for the recall is that the endosseous dental implants came into contact with a residual machine fluid, which caused the implants to become discolored. The source text does not report any illnesses, injuries, or adverse health consequences associated with this defect.
Healthcare professionals and patients who have received these specific implants should contact Biomet 3i, LLC for further instructions on how to proceed. Consumers should not use the affected implants if they have not yet been implanted.
The recalled product
- Product
- OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- 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 # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018
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
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
Similar recalls
- HighBiomet 3i Recalls Dental Implants Due to Residual Machining Fluid
FDA (Devices) · 2014-04-23
- LowBiomet 3i Recalls 92 Dental Implants Due to Packaging Error
FDA (Devices) · 2016-09-28
- HighBiomet 3i Recalls Dental Implants Due to Missing Internal Thread
FDA (Devices) · 2012-06-27
- SevereBiomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth
FDA (Devices) · 2012-11-28
- ModerateBiomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features
FDA (Devices) · 2013-09-25
- HighBiomet 3i Recalls Dental Implants Due to Missing Internal Threading
FDA (Devices) · 2012-10-31