Device product
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
Z-0237-2022
Product summary
- Firm
- OmniLife Science
- Event
- Event 88890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7
- Official record key
device-enforcement:Z-0237-2022
Official wording
Reason: The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Code information: UDI 00841690102496 Lot 38933
Distribution pattern: US Distribution to states of: Colorado and Virginia.
Derived failure modes
-
Unknown
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.