OMNI Hip System Model — Class II medical device recall Z-0169-2020
Terminated recall by OMNIlife science Inc., reported 2019-10-30, distributed in IL, OK. Stems missing porous coating on the device.
| Recall number | Z-0169-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OMNIlife science Inc., Raynham, MA, United States |
| Recall initiated | 2019-09-11 |
| Classified | 2019-10-21 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2020-04-27 |
| Distributed | IL, OK |
| Quantity | 3 units |
| Lot numbers | 33035 |
Product
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
Reason for recall
Stems missing porous coating on the device.
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-0169-2020. 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.