FDA-Device2019-10-30Class II
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
OMNIlife science Inc.
Hazard
Stems missing porous coating on the device.
Sold states
OK, IL
Affected count
3 units
Manufactured in
480 Paramount Dr, Raynham, MA, United States
Products
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0169-2020Don't want to check this manually?
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