Reported Nov 28, 2012 · Terminated
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior,…
Captiva Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Captiva Spine, Inc · 967 Alternate A1A · Jupiter, FL · 33477
Is this the product you have?
- 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.
- Lot codes and dates
- Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
- Amount recalled
- 10
Where it was sold
- Nationwide
- MN
Why it was recalled
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
This product could cause temporary or reversible health problems — stop using it.
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