Z-1712-2013 Class II Terminated
FDA device recall Z-1712-2013 was initiated by Biomet, Inc. on Jun 7, 2013 and is designated Class II. 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. The recall status is terminated (terminated Jul 17, 2014). Affected quantity: 46.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 17, 2013
- Initiation Date
- Jun 7, 2013
- Termination Date
- Jul 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46
Product Description
REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 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.
Distribution Pattern
Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
Code Information
M300790, M632920, M539410, M444850, M987620, M987310
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1712-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026