Device recall
Z-0837-2019: OMNI K1 Broach Handle, Product Code HS-10054
FDA device recall · Class II · OMNIlife science Inc.
Key facts
| Recall number (Z-number) | Z-0837-2019 |
|---|---|
| Recall event | 81951 |
| Product | OMNI K1 Broach Handle, Product Code HS-10054 |
| Product code | LXH |
| Recalling firm | OMNIlife science Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2020 |
| FEI number | 3008342029 |
At a glance
- None 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