Device recall
Z-0125-2008: Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile…
FDA device recall · Class II · Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Key facts
| Recall number (Z-number) | Z-0125-2008 |
|---|---|
| Recall event | 44854 |
| Product | Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138. |
| Product code | KWP |
| Recalling firm | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 14, 2009 |
| 510(k) numbers | K991031 |
| FEI number | 1824199 |
At a glance
- 1–9 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