FDA Device recall Z-1787-2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
- FDA Device
- Class II
- ongoing
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class II recall of RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component by Ossur H F, citing due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1787-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-25 |
| Published | 2024-05-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ossur H F |
| Distribution | US |
Product
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
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.
Identifiers
| code_info | UDI: 05690967598426/ Serial Number: HF377253 1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1787-2024%22
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