Z-2065-2015 Class II Terminated
FDA device recall Z-2065-2015 was initiated by Biomet, Inc. on Jun 3, 2015 and is designated Class II. Reason for recall: Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link. The recall status is terminated (terminated Mar 15, 2016). Affected quantity: 18.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 22, 2015
- Initiation Date
- Jun 3, 2015
- Termination Date
- Mar 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18
Product Description
Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. 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. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Reason for Recall
Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.
Code Information
Part Number: 32-423400 Lot Numbers: 238220, 664720,489620, 490930,021410, 507150
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2065-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026