Ossur H / F is recalling 251 units of its RHEO KNEE and RHEO KNEE XC prosthetic knees because of firmware defects. These issues can cause the prosthetic device to give unintended warnings or shut down suddenly without notice. This recall includes the RHEO KNEE with 2-year and 3-year warranties, as well as the RHEO KNEE XC with 3-year and 5-year warranties. Consumers were notified of this issue starting in March 2024 through letters sent to affected distributors and patients.
A firmware error can cause the prosthetic knee to shut down or malfunction during use, leading to a loss of stability. This poses a significant risk of patient falls, which could result in serious injury or bone fractures.
Contact healthcare provider or manufacturer for firmware resolution
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.