FDA-Device2019-09-11Class II
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
OMNIlife science Inc.
Hazard
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Sold states
US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
Affected count
6
Manufactured in
480 Paramount Dr, N/A, Raynham, MA, United States
Products
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2481-2019Don't want to check this manually?
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