OmniLife Science recalls OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OM
Recalled 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.
Hazard / Issue
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.
Issued by
FDA
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