Device recall
Z-1016-2009: Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor…
FDA device recall · Class II · Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Key facts
| Recall number (Z-number) | Z-1016-2009 |
|---|---|
| Recall event | 50185 |
| Product | Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in… |
| Product code | MNI |
| Recalling firm | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2009 |
| 510(k) numbers | K072317 |
| FEI number | 1824199 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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