Ossur H / F: RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

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.

Details from the source

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. Quantity: 1 unit Lot/code info: UDI: 05690977467811/ Serial Number: HF363264

UPC codes

05690977467811

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.