Recall Z-1788-2024— Ossur H / F

Name: FDA recall Z-1788-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-25

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: RKN130003, RHEO KNEE 3 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

RKN130003, RHEO KNEE 3 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.