Device recall
Z-1971-2021: Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D…
FDA device recall · Class II · Spes Medica
Key facts
| Recall number (Z-number) | Z-1971-2021 |
|---|---|
| Recall event | 87999 |
| Product | Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring. |
| Product code | ETN |
| Recalling firm | Spes Medica |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2022 |
| 510(k) numbers | K133348 |
| FEI number | 3011534533 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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