Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CapLOX II Final Torque Driver Recalled by Captiva Spine, Inc Due to Captiva Spine recalled their CapLOX II Final Torque...

Date: September 20, 2012
Company: Captiva Spine, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Captiva Spine, Inc directly.

Affected Products

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.

Quantity: 10

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Captiva Spine, Inc

Captiva Spine, Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report