Device recall
Z-1411-2008: Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic…
FDA device recall · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Recall number (Z-number) | Z-1411-2008 |
|---|---|
| Recall event | 46735 |
| Product | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901040, 10mm, 5.5mm dia x 40mm, size: 10mm x 40mm, for spinal fixation. |
| Product code | NQP |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2010 |
| 510(k) numbers | K060615 |
| FEI number | 1000477302 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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