Biomet, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1708-2013)

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:

REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Product Classification:

Class II

Date Initiated: June 7, 2013

Date Posted: July 17, 2013

Recall Number: Z-1708-2013

Event ID: 65459

Reason for Recall:

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Status: Terminated

Product Quantity: 24

Code Information:

M492970, M598310, M598310, M656980, M969150

Distribution Pattern:

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated