Device recall
Z-2461-2025: IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC…
FDA device recall · Class II · Medtronic Xomed, Inc.
Key facts
| Recall number (Z-number) | Z-2461-2025 |
|---|---|
| Recall event | 97266 |
| Product | IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the… |
| Product code | HBE |
| Recalling firm | Medtronic Xomed, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K111520 |
| FEI number | 1045254 |
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