FDA-Device2012-11-28Class II
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, f
Captiva Spine, Inc
Hazard
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Sold states
Nationwide Distribution (Distributed to one customer located in MN)
Affected count
10
Manufactured in
967 Alternate A1A, Suite1, Jupiter, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0413-2013Don't want to check this manually?
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