Yokohama, JP · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | 1 | 2024-03-04 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-03-25 | Class II | Ongoing | Z-2132-2026 | ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z | — | Resorbable bone void filler falls outside standard specifications. |
| 2026-03-25 | Class II | Ongoing | Z-2131-2026 | BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-K… | — | Resorbable bone void filler falls outside standard specifications. |