Biomet 3i, LLC: Medical Device Recall in 2012 - (Recall #: Z-0298-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides 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: September 28, 2012

Date Posted: November 28, 2012

Recall Number: Z-0298-2013

Event ID: 63618

Reason for Recall:

Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.

Status: Terminated

Product Quantity: 76 devices

Code Information:

Model Number IFOA411, Lot # 2011111333, 2011111333-S1

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France.

Voluntary or Mandated:

Voluntary: Firm initiated