FDAFDA · Food and drugs·Recall number Z-1787-2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Published May 22, 2024 · Recall initiated: March 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ossur H / F
- Distributor
- 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.
- Lot
- UDI: 05690967598426/ Serial Number: HF377253 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Iceland
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.