The Recall Desk
HighFDA (Devices)·Z-1828-2012·Announced 2012-06-27

Biomet 3i Recalls Dental Implants Due to Missing Internal Thread

Biomet 3i is recalling specific Osseotite dental implants because they may lack an internal thread. The recall affects 219 units distributed in the US and internationally.

What this means for you

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 is classified as FDA Class II. The hazard involves a structural defect (missing internal thread) in a medical device intended for surgical implantation, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomet 3i, LLC has initiated a recall of its Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. The recall was initiated on November 3, 2011, by the manufacturer located in Palm Beach Gardens, Florida. The specific defect identified is that the dental implant lot may not have an internal thread.

The recall involves 219 units in total. These products were distributed nationwide in the United States as well as in Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and the UK. The implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment for various dental restorations.

Healthcare providers and patients should check their inventory and records for implants matching the specific model and lot number listed in this recall. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor according to the recall instructions.

The recalled product

Product
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implants
Hazard
Affected units
219

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)

  • Lot #2010111529

Distribution

Distributed nationwide across the United States.

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