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.
Enforcement
- Recall Number
- Z-0413-2013
- Event ID
- 63633
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Captiva Spine, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Other
- Report Date
- November 28, 2012
- Initiation Date
- September 20, 2012
- Classification Date
- November 21, 2012
- Termination Date
- January 11, 2013
- Address
- 967 Alternate A1A, Suite1, Jupiter, FL, 33477, United States
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
Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
Nationwide Distribution (Distributed to one customer located in MN)
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