FDA Device recall Z-0169-2020
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…
- FDA Device
- Class II
- terminated
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of 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… by Omnilife Science, citing stems missing porous coating on the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0169-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-11 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Omnilife Science |
| Distribution | IL, OK |
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
Stems missing porous coating on the device.
Identifiers
| code_info | Lot # 33035 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0169-2020%22
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