FDA-Device2024-05-22Class II
RKNXC0003, RHEO KNEE XC 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
107 units
Manufactured in
Grjothals 5, N/A, Reykjavik, N/A, Iceland
Products
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1789-2024Don't want to check this manually?
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