CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spina...
FDA Device Recall #Z-0413-2013 — Class II — September 20, 2012
Recall Summary
| Recall Number | Z-0413-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 20, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Captiva Spine, Inc |
| Location | Jupiter, FL |
| Product Type | Devices |
| Quantity | 10 |
Product Description
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
Distribution Pattern
Nationwide Distribution (Distributed to one customer located in MN)
Lot / Code Information
Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
Other Recalls from Captiva Spine, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1480-2015 | Class II | Captiva's lumbar intervertebral fusion system R... | Feb 25, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.