CapLOX II Final Torque Driver, Indicator is a Pedicle screw… recallZ-0413-2013 · Captiva Spine, Inc · initiated Sep 20, 2012
Class II Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Captiva Spine, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
FDA root cause category: Nonconforming Material/Component
What the company is doing
Captiva Spine contacted the customer by phone to have them return the device. For questions regarding this recall call 561-277-9480.
Recall details
- Recall number
- Z-0413-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 20, 2012
- Posted by the FDA
- Nov 21, 2012
- Recalling firm
- Captiva Spine, Inc
- Quantity
- 10
- Product code
- MNI
- FDA submissions
- K120292
- Distribution
- Nationwide Distribution (Distributed to one customer located in MN)
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.
Code information (models, lots, serial numbers)
Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
Other devices under the same FDA submission
1 device cleared under K120292 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MIS Cannulated Polyaxial Screw, 6.5 x 45 2431-6545Captiva Spine, Inc. · Orthosis, Spondylolisthesis Spinal Fixation1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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