FDA recall Z-0169-2020

Product

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.

Reason for recall

Stems missing porous coating on the device.

Distribution

OK, IL

Key facts

Status

Terminated

Initiation date

2019-09-11

Report date

2019-10-30

Termination date

2020-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0169-2020