Class II

Medical Device Recall: RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

Ossur H / F · March 25, 2024

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.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

107 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1789-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Ossur H / F Medical Device Recall: RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component | SafeCheck