FDAFDA · Food and drugs·Recall number Z-0413-2013
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.
Published November 28, 2012 · Recall initiated: September 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Captiva Spine, Inc
- Distributor
- Nationwide Distribution (Distributed to one customer located in MN)
- Lot
- Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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