Ossur RHEO Knee XC Prosthetic Components Recall Due to Firmware Issues
Ossur is recalling 107 RHEO Knee XC prosthetic components due to firmware issues that may cause unintended device shutdown or warnings, risking patient falls.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prosthetic knee with potential for patient falls from unintended device shutdown. No injuries or deaths have been reported. Per the severity rubric, a risk-of-harm product without reported injury scores 3 (High).
Plain-English summary
Ossur H / F is recalling 107 units of the RHEO KNEE XC 3 YR WARRANTY prosthetic knee component due to firmware issues. These devices are distributed nationwide across all 50 U.S. states.
The recalled prosthetic knees may experience firmware-related malfunctions that trigger unintended warning messages or cause the device to shut down unexpectedly. An unexpected loss of function or shutdown could result in a patient fall.
Patients who use or own a RHEO KNEE XC 3 YR WARRANTY with one of the affected serial numbers should contact their prosthetist or healthcare provider immediately to confirm whether their device is affected.
Affected patients should consult with their healthcare provider to determine the appropriate next steps, which may include device replacement, firmware reprogramming, or removal from service pending a fix.
The recalled product
- Product
- RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Manufacturer
- Ossur H / F
- Category
- Medical Device — Prosthetic Knee
- Hazard
- device-shutdown
- unintended-warnings
- fall-risk
Distribution
Distributed nationwide across the United States.
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