PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 25, 2013 Initiated: June 10, 2013 #Z-2207-2013

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Biomet 3i, LLC
Units Affected
215
Distribution
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.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Biomet 3i, LLC. Units affected: 215.
Why was this product recalled?
One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 25, 2013. Severity: Moderate. Recall number: Z-2207-2013.