OMNIlife science — Class II medical device recall Z-2481-2019
Terminated recall by OMNIlife science Inc., reported 2019-09-11, distributed nationwide. Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear r
| Recall number | Z-2481-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OMNIlife science Inc., Raynham, MA, United States |
| Recall initiated | 2019-07-23 |
| Classified | 2019-09-05 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2020-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 6 |
| Lot numbers | 31707 |
Product
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
Reason for recall
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2481-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.