Recall Z-0413-2013 ยท MNI Orthosis, Spinal Pedicle Fixation
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
| Date | Nov 21, 2012 (initiated Sep 20, 2012) |
| Status | Terminated |
| 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120292 | CAPLOX II PEDICLE SCREW SYSTEM Captiva Spine, Inc., Apr 13, 2012 |