Biomet 3i, LLC OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
Brand
Biomet 3i, LLC
Lot Codes / Batch Numbers
Implant PN # IFNT3211 Lot # 2014051477 Exp date 12/06/2018
Products Sold
Implant PN # IFNT3211 Lot # 2014051477 Exp date 12/06/2018
Biomet 3i, LLC is recalling OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants. due to Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 13, 2026