FDA-Device2024-05-22Class II
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Ossur H / F
Hazard
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Sold states
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.
Affected count
143 units
Manufactured in
Grjothals 5, N/A, Reykjavik, N/A, Iceland
Products
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1788-2024Don't want to check this manually?
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