Device product
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
Z-0246-2023
Product summary
- Event
- Event 91016
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 devices
- Official record key
device-enforcement:Z-0246-2023
Official wording
Reason: The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Code information: Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.
Distribution pattern: US Nationwide distribution in the states of CA and NY.
Derived failure modes
-
Unknown
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.