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Recall Observatory FDA recall evidence

Device product

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.

Z-0413-2013

September 20, 2012

Class II

Product summary

Firm
Captiva Spine, Inc
Event
Event 63633
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-0413-2013

Official wording

Reason: Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking

Code information: Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.

Distribution pattern: Nationwide Distribution (Distributed to one customer located in MN)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking