Device recall
Z-2121-2020: LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function…
FDA device recall · Class II · Boston Scientific Neuromodulation Corporation
Key facts
| Recall number (Z-number) | Z-2121-2020 |
|---|---|
| Recall event | 84983 |
| Product | LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain… |
| Product code | LGW |
| Recalling firm | Boston Scientific Neuromodulation Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 18, 2022 |
| PMA numbers | P030017 |
| FEI number | 3006630150 |
At a glance
- None 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