Z-2250-2021 Class II
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 devices
Product Description
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Reason for Recall
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
Distribution Pattern
US Nationwide Distribution
Code Information
Serial Numbers: 6465589-6465618; 6465641