Device recall
Z-1912-2008: Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS)…
FDA device recall · Class II · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-1912-2008 |
|---|---|
| Recall event | 48070 |
| Product | Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only, |
| Product code | LGW |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2012 |
| PMA numbers | P840001, P840001S075 |
| FEI number | 2182207 |
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