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U.S. Department of Health and Human Services

Class 2 Device Recall CapLOX II Pedicle Screw System

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  Class 2 Device Recall CapLOX II Pedicle Screw System see related information
Date Initiated by Firm September 20, 2012
Date Posted November 21, 2012
Recall Status1 Terminated 3 on January 11, 2013
Recall Number Z-0413-2013
Recall Event ID 63633
510(K)Number K120292  
Product Classification Orthosis, spinal pedicle fixation - Product Code MNI
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.
Code Information Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
Recalling Firm/
Manufacturer		 Captiva Spine, Inc
967 Alternate A1A
Suite1
Jupiter FL 33477
For Additional Information Contact
561-277-9480
Manufacturer Reason
for Recall		 Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
FDA Determined
Cause 2		 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)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MNI and Original Applicant = CAPTIVA SPINE, INC
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