CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, n
FDA device recall Z-0413-2013 · posted 2012-11-21 · Terminated
Recall details
- Recalling firm
- Captiva Spine, Inc
- Reason for recall
- Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
- Action taken
- Captiva Spine contacted the customer by phone to have them return the device. For questions regarding this recall call 561-277-9480.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 10
- Distribution
- Nationwide Distribution (Distributed to one customer located in MN)
- Date initiated
- 2012-09-20
- Date posted
- 2012-11-21
- Date terminated
- 2013-01-11
- Location
- Jupiter, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAPLOX II PEDICLE SCREW SYSTEM (K120292) | Captiva Spine, Inc. | 2012-04-13 |