Class II — Captiva Spine, Inc
| Recalling firm | CAPTIVA SPINE |
|---|---|
| Registered facility | CAPTIVA SPINE, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking |
| 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. |
| Quantity | 10 |
| Distribution | Nationwide Distribution (Distributed to one customer located in MN) |
| Initiated | 2012-09-20 |
| Classified | 2012-11-21 |
| Terminated | 2013-01-11 |
| Recall number | Z-0413-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Captiva Spine, Inc (Z-0413-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63633/
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