The Recall Desk
LowFDA (Devices)·Z-1411-2015·Announced 2015-04-22

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.

What this means for you

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

Distributed nationwide across the United States.

The notice also names 27 states specifically:

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 →

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