FDA Device recall Z-0413-2013
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system by Captiva Spine, citing captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0413-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-20 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Captiva Spine |
| Distribution | US |
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 of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
Reason
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Identifiers
| code_info | Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0413-2013%22
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