Device recall
Z-0199-2008: Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1…
FDA device recall · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Recall number (Z-number) | Z-0199-2008 |
|---|---|
| Recall event | 44967 |
| Product | Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000214, Manufactured at: Warsaw, Indiana, USA |
| Product code | NVR |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2009 |
| FEI number | 1000477302 |
At a glance
- None 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