Device product
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Z-1350-2020
Product summary
- Event
- Event 84638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 179 units
- Official record key
device-enforcement:Z-1350-2020
Official wording
Reason: Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
Code information: Lot Numbers: U010577, U016620, U019084
Distribution pattern: AZ, TX, GA, FL, AR, CA
Derived failure modes
-
Manufacturing or process control
production error