CapLOX II Final Torque Driver — Class II medical device recall Z-0413-2013
Terminated recall by Captiva Spine, Inc, reported 2012-11-28, distributed nationwide. Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
| Recall number | Z-0413-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Captiva Spine, Inc, Jupiter, FL, United States |
| Recall initiated | 2012-09-20 |
| Classified | 2012-11-21 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Lot numbers | 06110093 |
| Model numbers | 2201-5004 |
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 for recall
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0413-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.