Official recall notice
FDA DeviceClass IINotable
FDA Recall: BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0
- 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
1266
Product description
Resorbable bone void filler falls outside standard specifications.