Recall Z-0413-2013— Captiva Spine, Inc

Name: FDA recall Z-0413-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-20

Class II · Terminated

Class II FDA medical device recall by Captiva Spine, Inc, initiated 2012-09-20, terminated 2013-01-11. It names one FDA 510(k) clearance: K120292. 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.. Reason: Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking.

Recalling firm: Captiva Spine, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Terminated: 2013-01-11
Firm location: Jupiter, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K120292 — CAPLOX II PEDICLE SCREW SYSTEMCaptiva Spine, Inc.·cleared 2012-04-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.