Ossur recalls specific prosthetic knee models due to firmware issues that could cause unintended warnings and device shutdowns, potentially leading to patient falls. Affected units include RKN130003 and RHEO KNEE models with serial numbers listed.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Ossur is recalling certain prosthetic knee components because firmware issues might cause the device to shut down unexpectedly or give false warnings, which could lead to falls. This is a safety concern for users who rely on these prosthetics.
The prosthetic knee's firmware has issues that can cause it to shut down unexpectedly or display false warnings. This could lead to the user losing balance and falling, especially during movement or when the device is critical for stability.
People who own or use the recalled Ossur RKN130003 or RHEO KNEE prosthetic knee models with the listed serial numbers are most at risk. These users may experience falls if the device shuts down unexpectedly.
Check if your prosthetic knee has the model RKN130003 or RHEO KNEE with the serial numbers listed in the recall notice. The device includes a unique identifier (UDI) starting with 05690967595418.
Look for the unique identifier (UDI) starting with 05690967595418 on the prosthetic knee to confirm if it's affected.
Reach out to Ossur directly to confirm if your specific model is recalled and get guidance on next steps.
The recall is due to firmware issues that could cause unintended shutdowns or false warnings, potentially leading to falls.
No, but you should check if your device is affected and contact Ossur for guidance, as the hazard requires caution rather than immediate stoppage.
Check for the unique identifier (UDI) starting with 05690967595418 or the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-1788-2024 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-1788-2024 from Ossur. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.