Z-0413-2013Class II

CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a...

Name: Z-0413-2013 CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a...
Creator: Captiva Spine, Inc
Published: 2012-09-20
License: https://open.fda.gov/license/

CAPTIVA SPINE, Inc. / initiated 2012-09-20 / Terminated / root cause: manufacturing process

FDA source

Captiva Spine, Inc began a recall of 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... on 2012-09-20. FDA classified it as Class II and gives the reason as "Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0413-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Posted: 2012-11-21
Terminated: 2013-01-11
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.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Root cause tag: manufacturing process
FDA 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 in commerce: 10
Distribution: Nationwide Distribution (Distributed to one customer located in MN)
Product codes and lots: Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0413-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0413-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

Product code MNI

K120292Class IICaplox II Pedicle Screw SystemCaptiva Spine, Inc. / cleared 2012-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)