# FDA recall Z-0922-2021

> **OMNIlife science Inc.** · Class II · device recall initiated 2020-12-21.

## Product

SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures.    Product Code: H6-24928

## Reason for recall

Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a  revision surgery

## Distribution

AL, ID, MD, NY, OK

## Key facts

- **Recall number:** Z-0922-2021
- **Recalling firm:** OMNIlife science Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-21
- **Report date:** 2021-02-03
- **Termination date:** 2021-06-10

- **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-0922-2021

## Citation

> AI Analytics. FDA recall Z-0922-2021. Retrieved 2026-08-13 from https://api.ai-analytics.org/recall/Z-0922-2021. Source: US FDA. Licensed CC0.

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