Device recall
Z-0869-2021: Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product…
FDA device recall · Class II · The Magstim Company Limited
Key facts
| Recall number (Z-number) | Z-0869-2021 |
|---|---|
| Recall event | 87063 |
| Product | Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures. |
| Product code | ETN |
| Recalling firm | The Magstim Company Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 16, 2023 |
| 510(k) numbers | K923056 |
| FEI number | 3002808356 |
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