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.
FDA Recall Z-0413-2013 · Posted 2012-11-21
Advertisement
Recalling FirmCaptiva Spine, Inc
Recall StatusTerminated
Product CodeMNI
Date Initiated2012-09-20
Date Terminated2013-01-11
Product Quantity10
Reason for Recall
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Firm Action
Captiva Spine contacted the customer by phone to have them return the device.
For questions regarding this recall call 561-277-9480.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution (Distributed to one customer located in MN)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement