Recall Z-1711-2013— Biomet, Inc.

Name: FDA recall Z-1711-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-07

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2013-06-07, terminated 2014-07-17. It names one FDA 510(k) clearance: K122277. Product: REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 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.. Reason: 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Terminated: 2014-07-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing Corp·cleared 2012-10-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.