Official recall notice
FDA DeviceClass IINotable
FDA Recall: ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
- Recall date
- 2026-05-13
- Brand
- Orthorebirth Co Ltd
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Resorbable bone void filler falls outside standard specifications.
Recommended action
What to do
20
Product description
Resorbable bone void filler falls outside standard specifications.