Device recall
Z-2718-2014: Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of…
FDA device recall · Class II · St. Jude Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2718-2014 |
|---|---|
| Recall event | 69025 |
| Product | Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. |
| Product code | GZB |
| Recalling firm | St. Jude Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2015 |
| 510(k) numbers | K123299 |
| FEI number | 1627487 |
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