Device recall
Z-2931-2020: StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product…
FDA device recall · Class II · Stimwave Technologies Inc
Key facts
| Recall number (Z-number) | Z-2931-2020 |
|---|---|
| Recall event | 86115 |
| Product | StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field… |
| Product code | GZF |
| Recalling firm | Stimwave Technologies Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K152178, K171366 |
| FEI number | 3010676138 |
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