Recall Z-2213-2026 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Novapproach Spine, LLC
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, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small, 13 Degree 10mm X 6mm, 010-113-1006-2/Small, 13 Degree, 10mm X 6mm - Oblique, 010-113-1208/Small 13 Degree 12mm X 8mm, 010-113
| Date | May 20, 2026 (initiated Apr 23, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| Action | On 4/23/2026, removal notices were sent to customers who were asked to do the following: 1) Return affected devices using the return label. 2) Firm is providing unaffected kits. If you have recall-related questions contact firm at Ron.Green@NovApproachspine.com |
| Quantity | 1259 |
| Distribution | US Nationwide distribution in the states of NY, CT, CA, TX, FL, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211769 | OneLIF Intervertebral Body Replacement System Novapproach Spine, Sep 7, 2021 |