FDA-Device2021-11-24Class II
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.
OmniLife Science
Hazard
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.
Sold states
US Distribution to states of: Colorado and Virginia.
Affected count
7
Manufactured in
480 Paramount Dr, N/A, Raynham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0237-2022Don't want to check this manually?
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