Device recall
Z-2257-2024: Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve…
FDA device recall · Class II · Nalu Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2257-2024 |
|---|---|
| Recall event | 94682 |
| Product | Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System. |
| Product code | GZF |
| Recalling firm | Nalu Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183047, K183579 |
| FEI number | 3015425075 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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