Fremont, CA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QVV | — | — | — | 1 | 2023-04-10 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-12-02 | Class II | Ongoing | Z-0762-2025 | MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002. | — | Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that ma… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-04-10 | DEN220033 | MISHA Knee System | QVV | — | — |