Device recall
Z-0169-2020: OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use…
FDA device recall · Class II · OMNIlife science Inc.
Key facts
| Recall number (Z-number) | Z-0169-2020 |
|---|---|
| Recall event | 83844 |
| 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. |
| Product code | LPH |
| Recalling firm | OMNIlife science Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2020 |
| 510(k) numbers | K060072 |
| FEI number | 3008342029 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database