OneLIF Torque Limiting Adapter — Class II medical device recall Z-0246-2023
Terminated recall by Novapproach Spine LLC, reported 2022-11-23, distributed nationwide. The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
| Recall number | Z-0246-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novapproach Spine LLC, Alachua, FL, United States |
| Recall initiated | 2022-10-12 |
| Classified | 2022-11-17 |
| Reported by FDA | 2022-11-23 |
| Terminated | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 6 devices |
| Lot numbers | 104713 |
| Model numbers | 015-010-0000 |
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 for recall
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0246-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.