Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 28, 2012
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, f
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Captiva Spine, Inc recalled CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX … - a moderate-severity action.
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX … was recalled by Captiva Spine, Inc in November 28, 2012. Reason: Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking. Check the official notice for the remedy. Verify recall #Z-0413-2013 with the FDA Devices before acting.
The recall
Captiva Spine, Inc issued this moderate-severity FDA Devices recall-Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking.
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- November 28, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0413-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0413-2013) was formally reported on November 28, 2012, with the manufacturer initiating the action on September 20, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Captiva Spine, Inc is listed as the recalling firm, operating out of Jupiter, FL. Federal records list the affected scope as 10.
The documented reason for this recall is: Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking Distribution data in the federal record shows the product reached: Nationwide Distribution (Distributed to one customer located in MN). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10
Related Recalls
6
3 from same agency
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.
Reason for recall
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0413-2013 |
| Date reported | November 28, 2012 |
| Date initiated | September 20, 2012 |
| Recalling firm | Captiva Spine, Inc |
| Firm location | Jupiter, FL |
| Affected scope | 10 |
| Distribution | Nationwide Distribution (Distributed to one customer located in MN) |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0413-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Captiva Spine, Inc. Units affected: 10.
Why was this product recalled? ▼
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0413-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution (Distributed to one customer located in MN).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0413-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 28, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.