Device product
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Z-0849-2018
Product summary
- Event
- Event 79072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 130 units total
- Official record key
device-enforcement:Z-0849-2018
Official wording
Reason: Potential for Intra-operative breakage of driver tips
Code information: Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Potential for Intra-operative breakage of driver tips