Biomet 3i, LLC recalls Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the

Recalled September 25, 2013 · FDA recall Z-2207-2013 · Biomet 3i

Hazard

One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature. · FDA Class II

Units

215

Sold at

Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, France, Switzerland, Apain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal, and the United Kingdom.

Description

One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.

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 teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.

Manufacturer(s)

Biomet 3i, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →