Kitchener, CA · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2021-11-12 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-02-11 | Class II | Terminated | Z-1559-2020 | Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation S… | — | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. |