Prosthetic Knee Firmware Defect Risks Unintended Shutdown and Patient Falls
The RKNXC0005 RHEO KNEE XC prosthetic knee may experience firmware issues causing unintended warnings and device shutdown, creating a fall risk for patients.
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 a risk-of-harm medical device with FDA Class II classification where injury has not yet been reported. The firmware defect creates potential for device shutdown and patient falls, but no illnesses or injuries are mentioned in the source, qualifying it as Score 3 per the rubric.
Plain-English summary
The RKNXC0005 RHEO KNEE XC prosthetic knee, manufactured by Ossur H / F, is being recalled due to a firmware defect in the device.
The firmware issue can cause unintended warning alerts or unexpected device shutdown. An unexpected shutdown may cause patients to lose stability and fall.
This recall affects patients nationwide who received this prosthetic knee component. It was distributed across multiple states throughout the United States.
Patients using this prosthetic knee should contact their prosthetist or the manufacturer immediately regarding this recall.
The recalled product
- Product
- RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Manufacturer
- Ossur H / F
- Category
- Medical Device — Prosthetic Limb
- Hazard
- firmware-defect
- device-shutdown
- fall-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 05690977467811/ Serial Number: HF363264
Distribution
Distributed nationwide across the United States.
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