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.
Reported: November 24, 2021 Initiated: October 1, 2021 #Z-0237-2022
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- OmniLife Science
- Units Affected
- 7
- Distribution
- US Distribution to states of: Colorado and Virginia.
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by OmniLife Science. Units affected: 7.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0237-2022.
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