Recall Z-1787-2024— Ossur H / F
Class II · Ongoing
Class II FDA medical device recall by Ossur H / F, initiated 2024-03-25. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Ossur H / F
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-25
- Firm location
- Reykjavik, N/A, Iceland
Product description
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Reason for recall
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Data sourced from openFDA. This site is unofficial and independent of the FDA.