Ossur H / F: Medical Device Recall in 2024 - (Recall #: Z-1787-2024)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2024.
Data Source: FDA.
Product Description:
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Product Classification:
Class II
Date Initiated: March 25, 2024
Date Posted: May 22, 2024
Recall Number: Z-1787-2024
Event ID: 94332
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.
Status: Ongoing
Product Quantity: N/A
Code Information:
UDI: 05690967598426/ Serial Number: HF377253 1
Distribution Pattern:
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.
Voluntary or Mandated:
Voluntary: Firm initiated