Device product
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Z-2250-2021
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 88259
- Status
- Completed
- Classification
- Class II
- Quantity
- 29 devices
- Official record key
device-enforcement:Z-2250-2021
Official wording
Reason: 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).
Code information: Serial Numbers: 6465589-6465618; 6465641
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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).