---
title: "OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is ... — FDA record Z-0237-2022 | Is It on Recall"
description: "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 undersizi"
url: https://isitonrecall.com/recall/fda-device-z-0237-2022-omni-k2-hip-stem-manufacturer-s-product-code-130006-the-omni-k2-hip-stem-is-intended-for-use-as-the/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral componen... — FDA record Z-0237-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 1, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class II
- **Recalling firm**: OmniLife Science
- **Quantity**: 7
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0237-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0237-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI 00841690102496 Lot 38933 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US Distribution to states of: Colorado and Virginia.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Colorado](https://isitonrecall.com/state/colorado/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Nov 24, 2021
- **Recall initiation date**: Oct 1, 2021
- **Center classification date**: Nov 16, 2021
- **Termination date**: Jul 20, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0237-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [OmniLife Science records](https://isitonrecall.com/brand/omnilife-science/)