The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2207-2013·Announced 2013-09-25

Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features

Biomet 3i is recalling 215 Osseotite 2 Certain Prevail dental implants because some units lack the internal hex and thread features required for proper prosthetic attachment.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries. The hazard is a functional defect (missing internal features) rather than a toxicological or acute safety risk, fitting the criteria for a moderate severity score.

Plain-English summary

Biomet 3i, LLC is recalling 215 units of the Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant. The recall is due to a manufacturing defect where some of the dental implants do not have the internal hex feature and some do not have the internal thread feature. These features are necessary for the surgical placement of the implant and the subsequent attachment of prosthetic teeth.

The affected products were distributed worldwide, including nationwide in the United States and in several international countries such as Canada, Japan, Australia, and the United Kingdom. The specific product code for the recalled items is XIIOS5411.

Consumers and healthcare providers who have purchased or used these specific dental implants should contact Biomet 3i, LLC for further instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single…
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implant
Hazard
Affected units
215

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)

  • XIIOS5411

Distribution

Distributed nationwide across the United States.

The notice also names 19 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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