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.
Recall
- Recall Number
- Z-0413-2013
- Event Number
- 63633
- Firm
- Captiva Spine, Inc 967 Alternate A1A Suite1
- FEI Number
- 3006082533
- Product Code
- MNI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 20, 2012
- Posted
- November 21, 2012
- Terminated
- January 11, 2013
- Address
- Jupiter, FL, 33477
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.
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Captiva Spine contacted the customer by phone to have them return the device. For questions regarding this recall call 561-277-9480.
Nationwide Distribution (Distributed to one customer located in MN)
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