Device product
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
Z-0169-2020
Product summary
- Event
- Event 83844
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0169-2020
Official wording
Reason: Stems missing porous coating on the device.
Code information: Lot # 33035
Distribution pattern: OK, IL
Derived failure modes
-
Unknown
Stems missing porous coating on the device.