The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0298-2013·Announced 2012-11-28

Biomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth

Biomet 3i is recalling 76 OSSEOTITE dental implants because a manufacturing defect makes the internal hex too shallow, potentially preventing proper engagement of drivers or abutments.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that may prevent proper engagement of components, posing a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Biomet 3i, LLC is recalling 76 units of the Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The recall also covers the Full OSSEOTITE 2 Tapered Certain Implant. These sterile dental implants are used for prosthetic attachment in single tooth restorations and edentulous spans.

The recall is due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This defect may prevent the driver or abutment from fully engaging in the implant. The affected devices are identified by Model Number IFOA411 and Lot # 2011111333 or 2011111333-S1.

The affected devices were distributed worldwide, including nationwide in the United States and in countries such as the United Kingdom, Germany, Canada, and Japan. The source text does not specify reported injuries or illnesses associated with this defect.

The recalled product

Product
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or…
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implants
Hazard
Affected units
76

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 (3)

  • Model Number IFOA411
  • Lot # 2011111333
  • 2011111333-S1

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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