Ossur H / F Recall 94332
Description: RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Ossur H / F Recall 94332 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1787-2024 |
| Event ID | 94332 |
| Event Description | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY. |
| Quantity | N/A |
| Recall Reason | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. |
| Device Classification | 20240522 |
| Device Code Info | UDI: 05690967598426/ Serial Number: HF377253 1 |
| Center Classification Date | 20240510 |
| Recall Initiation Date | 20240325 |
| Recalling Firm | Ossur H / F |
| Initial Notification | Letter |
| Similar To |