Device product
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Z-1616-2016
Product summary
- Event
- Event 73657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16
- Official record key
device-enforcement:Z-1616-2016
Official wording
Reason: The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Code information: Lots #: 8887, 000073, 000135, 00434, and 02518.
Distribution pattern: Nationwide Distribution to FL, MO, and WV.
Derived failure modes
-
Unknown
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.