Z-0413-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- September 20, 2012
- Termination Date
- January 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product 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.
Reason for Recall
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Distribution Pattern
Nationwide Distribution (Distributed to one customer located in MN)
Code Information
Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.