Captiva Spine, Inc: Medical Device Recall in 2012 - (Recall #: Z-0413-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 20, 2012

Date Posted: November 28, 2012

Recall Number: Z-0413-2013

Event ID: 63633

Reason for Recall:

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

Status: Terminated

Product Quantity: 10

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)

Voluntary or Mandated:

Voluntary: Firm initiated