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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

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

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 Other
Distribution Pattern Nationwide Distribution (Distributed to one customer located in MN)