Reported Nov 24, 2021 · Terminated
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component…
OmniLife Science
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OmniLife Science · 480 Paramount Dr · Raynham, MA · 02767-1085
Is this the product you have?
- 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.
- Lot codes and dates
- UDI 00841690102496 Lot 38933
- Amount recalled
- 7
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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