Z-1787-2024 Class II Ongoing
FDA device recall Z-1787-2024 was initiated by Ossur H / F on March 25, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- March 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
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 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.
Code Information
UDI: 05690967598426/ Serial Number: HF377253 1