Z-0246-2023 Class II Terminated
FDA device recall Z-0246-2023 was initiated by Novapproach Spine LLC on October 12, 2022 and is designated Class II. Reason for recall: The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. The recall status is terminated (terminated April 1, 2026). Affected quantity: 6 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 23, 2022
- Initiation Date
- October 12, 2022
- Termination Date
- April 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 devices
Product Description
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.
Reason for Recall
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Distribution Pattern
US Nationwide distribution in the states of CA and NY.
Code Information
Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.