Alachua, FL, United States
Novapproach Spine LLC recalls
2 recalls recorded since 2018, most recently on 23 April 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 April 2026
- Reason
- Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
- Distribution
- US Nationwide distribution in the states of NY, CT, CA, TX, FL, MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2213-2026
- OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 0
Terminated Class II Medical devices
- Recall started
- 12 October 2022
- Terminated
- 1 April 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 instrument kit, Catalog #OneLIF INS.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.