OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7m
FDA device recall Z-2213-2026 · posted 2026-05-20 · Open, Classified
Recall details
- Recalling firm
- Novapproach Spine, LLC
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- OVD
- Quantity affected
- 1259
- Distribution
- US Nationwide distribution in the states of NY, CT, CA, TX, FL, MI.
- Date initiated
- 2026-04-23
- Date posted
- 2026-05-20
- Location
- Alachua, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OneLIF Intervertebral Body Replacement System (K211769) | Novapproach Spine | 2021-09-07 |