OmniLife Science: Medical Device Recall in 2021 - (Recall #: Z-0237-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 1, 2021

Date Posted: November 24, 2021

Recall Number: Z-0237-2022

Event ID: 88890

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.

Status: Terminated

Product Quantity: 7

Code Information:

UDI 00841690102496 Lot 38933

Distribution Pattern:

US Distribution to states of: Colorado and Virginia.

Voluntary or Mandated:

Voluntary: Firm initiated