Zuchwil, CH · 7 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 4 | 2026-03-09 |
| — | — | — | — | 1 | 2026-03-10 |
| GXN | — | — | — | 1 | 2025-11-12 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General Hospital | 1 | 2025-03-28 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-06-18 | Class II | Terminated | Z-2698-2020 | MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton… | — | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm scr… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-10 | K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | — | — | — |
| 2026-03-09 | K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | HRS | Class II | Orthopedic |
| 2026-03-02 | K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | HRS | Class II | Orthopedic |
| 2025-11-12 | K243715 | Synthes Patient Specific Implants | GXN | — | — |
| 2025-03-28 | K241927 | Synthes Graphic Case & Tray System | KCT | Class II | General Hospital |
| 2024-07-26 | K233994 | VOLT Proximal Humerus 3.5 Plating System | HRS | Class II | Orthopedic |
| 2024-05-09 | K233967 | DePuy Synthes MatrixSTERNUM Fixation System | HRS | Class II | Orthopedic |