FDA Device recall Z-0246-2023
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System…
- FDA Device
- Class II
- terminated
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System… by Novapproach Spine, citing the torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0246-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-12 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Novapproach Spine |
| Distribution | US |
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.
Reason
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Identifiers
| code_info | Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0246-2023%22
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