Device recall
Z-2122-2020: The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of…
FDA device recall · Class II · Boston Scientific Neuromodulation Corporation
Key facts
| Recall number (Z-number) | Z-2122-2020 |
|---|---|
| Recall event | 84983 |
| Product | The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with… |
| 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