Official recall notice
FDA DeviceClass IINotable
FDA Recall: OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Sm
- Recall date
- 2026-05-27
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
1259
Product description
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.