Device recall
Z-2241-2008: Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS)…
FDA device recall · Class II · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-2241-2008 |
|---|---|
| Recall event | 48705 |
| Product | Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical… |
| Product code | GZB |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2010 |
| 510(k) numbers | K971756 |
| FEI number | 2182207 |
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