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Captiva Spine, Inc recalls CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior
Recalled November 28, 2012 · FDA recall Z-0413-2013 · Captiva Spine
Hazard
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking · FDA Class II
Units
10
Sold at
Nationwide Distribution (Distributed to one customer located in MN)
Description
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.
Manufacturer(s)
Captiva Spine, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →