Ossur recalls external lower limb prosthetic components with firmware issues that could cause unintended shutdowns and patient falls. Affected units have specific serial numbers and warranty details.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Oss: Ossur has recalled external lower limb prosthetic components due to firmware issues that may cause unintended warnings and device shutdowns, potentially leading to falls. This affects users who have the specific serial numbers listed in the recall.
The prosthetic knee's firmware has issues that can cause unintended warnings and device shutdowns. These problems may lead to the user losing support and falling, especially during movement.
Users of Ossur's external lower limb prosthetic components with the specific serial numbers listed in the recall are most at risk. This includes individuals who have the RKN130002 model with the serial number HF377253.
Check for the serial number HF377253 on the device. The product is part of the RKN130002 model with a 2-year warranty, MD, CE markings, and the UDI code 05690967598426.
Review the device for unintended warnings or shutdowns that could cause falls.
Reach out to Ossur for guidance on the specific model and remedy options.
The recalled model is RKN130002 with the serial number HF377253.
The recall is due to firmware issues that can cause unintended warnings and device shutdowns, potentially leading to falls.
Check for the serial number HF377253 on the device. The product has UDI code 05690967598426 and is part of the RKN130002 model.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-1787-2024 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-1787-2024 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.