# FDA recall Z-0246-2023

> **Novapproach Spine LLC** · Class II · device recall initiated 2022-10-12.

## 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.

## Distribution

US Nationwide distribution in the states of CA and NY.

## Key facts

- **Recall number:** Z-0246-2023
- **Recalling firm:** Novapproach Spine LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-10-12
- **Report date:** 2022-11-23
- **Termination date:** 2026-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alachua, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0246-2023

## Citation

> AI Analytics. FDA recall Z-0246-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0246-2023. Source: US FDA. Licensed CC0.

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