FDA Medical Device Recalls (openFDA)
Captiva Spine, Inc: 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.
- Recall number
- Z-0413-2013
- Recalling firm
- Captiva Spine, Inc
- 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.
- Status
- Terminated
- Initiated
- 2012-09-20
- Posted
- 2012-11-21
- Terminated
- 2013-01-11
- Reason
- Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
- Root cause
- Nonconforming Material/Component
- Action
- Captiva Spine contacted the customer by phone to have them return the device. For questions regarding this recall call 561-277-9480.
- Quantity
- 10
- Distribution
- Nationwide Distribution (Distributed to one customer located in MN)
- Lot, serial or model codes
- Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
- 510(k) numbers
- ["K120292"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3006082533
- Firm city
- Jupiter
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28