Class II — Novapproach Spine LLC
| Recalling firm | NovApproach Spine, LLC |
|---|---|
| Registered facility | NOVAPPROACH SPINE, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. |
| 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. |
| Quantity | 6 devices |
| Distribution | US Nationwide distribution in the states of CA and NY. |
| Initiated | 2022-10-12 |
| Classified | 2022-11-17 |
| Terminated | 2026-04-01 |
| Recall number | Z-0246-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Novapproach Spine LLC (Z-0246-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91016/
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