FDA recall Z-2481-2019

OMNIlife science Inc. · Class II · device

Product

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

Reason for recall

Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

Distribution

US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.

Key facts

Status
Terminated
Initiation date
2019-07-23
Report date
2019-09-11
Termination date
2020-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2481-2019