# FDA recall Z-0237-2022

> **OmniLife Science** · Class II · device recall initiated 2021-10-01.

## 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

- **Recall number:** Z-0237-2022
- **Recalling firm:** OmniLife Science
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0237-2022. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0237-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*