Device recall
Z-0413-2013: CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The…
FDA device recall · Class II · Captiva Spine, Inc
Key facts
| Recall number (Z-number) | Z-0413-2013 |
|---|---|
| Recall event | 63633 |
| Product | CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment… |
| Product code | MNI |
| Recalling firm | Captiva Spine, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 2013 |
| 510(k) numbers | K120292 |
| FEI number | 3006082533 |
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