FDA recall Z-0237-2022

Product

OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.

Reason for recall

The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.

Distribution

US Distribution to states of: Colorado and Virginia.

Key facts

Status

Terminated

Initiation date

2021-10-01

Report date

2021-11-24

Termination date

2022-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0237-2022