The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0297-2013·Announced 2012-11-28

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

Biomet 3i is recalling 191 OSSEOTITE dental implants because a manufacturing defect makes the internal hex too shallow, which may prevent the driver or abutment from fully engaging.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).

Plain-English summary

Biomet 3i, LLC is recalling 191 units of the Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, size 4 x 13 mm. The recall also covers the Full OSSEOTITE Parallel Walled Certain Implant. The affected devices are sterile and are used for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans.

The recall is due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant. The agency has classified this as a Class II recall.

The affected devices were distributed nationwide in the United States, including in Virginia, South Carolina, Hawaii, Louisiana, Ohio, Florida, Illinois, New Jersey, North Carolina, California, Connecticut, Michigan, Tennessee, Alaska, New Hampshire, New York, Massachusetts, Georgia, Pennsylvania, and Kentucky. They were also distributed in the United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France. The specific lot number is 2012040462. Consumers and healthcare providers should contact Biomet 3i for further instructions regarding the affected devices.

The recalled product

Product
Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. 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…
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implants
Hazard
Affected units
191

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 (2)

  • Model Number XIFNT413
  • Lot # 2012040462

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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