FDA recall Z-2479-2019

Product

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328

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-2479-2019