Device product
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Z-0454-2016
Product summary
- Event
- Event 72654
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 devices
- Official record key
device-enforcement:Z-0454-2016
Official wording
Reason: Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length
Code information: LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134
Distribution pattern: US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
Derived failure modes
-
Manufacturing or process control
Manufacturing error