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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 63633
Product Type Devices
Status Ongoing
Recalling Firm Captiva Spine, Inc
City Jupiter
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution (Distributed to one customer located in MN)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110. Class II Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking 10 Z-0413-2013