CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report
CapLOX II Final Torque Driver recalled by Captiva Spine
Captiva Spine is recalling CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system, distributed nationwide in the US. The recall was initiated on 20 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0413-2013
- FDA event ID
- 63633
- Recalling firm
- Captiva Spine, Jupiter, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Sep 2012
- FDA classified
- 21 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 20 Sep 2012 | Recall initiated by company | |
| 21 Nov 2012 | Classified by FDA | +62 days |
| 28 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution (Distributed to one customer located in MN)
Questions about this recall
Is CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system recalled?
Yes. Captiva Spine recalled CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system on 20 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0413-2013.
Why was it recalled?
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Which lots are affected?
Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
Where was it sold?
Nationwide Distribution (Distributed to one customer located in MN)
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Captiva Spine
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Captiva's lumbar intervertebral fusion system Reamers (color recalled | Captiva Spine | Other | 7 states |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |