Device recall
Z-1014-2009: Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain…
FDA device recall · Class II · Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Key facts
| Recall number (Z-number) | Z-1014-2009 |
|---|---|
| Recall event | 50185 |
| Product | Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system… |
| 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