Biomet 3i, LLC: Medical Device Recall in 2013 - (Recall #: Z-2207-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 10, 2013

Date Posted: September 25, 2013

Recall Number: Z-2207-2013

Event ID: 66204

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.

Status: Terminated

Product Quantity: 215

Code Information:

XIIOS5411

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated