Ossur H F Grjothals 5 Reykjavik Iceland RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
Brand
Ossur H F Grjothals 5 Reykjavik Iceland
Lot Codes / Batch Numbers
UDI: 05690977467811/ Serial Number: HF363264
Products Sold
UDI: 05690977467811/ Serial Number: HF363264
Ossur H F Grjothals 5 Reykjavik Iceland is recalling RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component due to Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient fall. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Recommended Action
Per FDA guidance
On April 4, 2024, Ossur, issued a Urgent Medical Device Correction via E-Mail to affected consignees. Ossur asked consignees to take the following actions: REMOTELY UPDATE FIRMWARE ON AFFECTED DEVICES 1a. Check the serial number of devices against the list of affected devices in this letter to confirm the affected units. 2b. Update the firmware on the device via the Rheo Knee Update application This application can only be used to update the affected devices: i. A computer running Windows Operating System 10 or 11 is required to run the Rheo Knee Update application. It is not compatible with Android or iOS and cannot be completed via mobile phones. ii. Access the Rheo Knee Update application via this link: htps://www.ossur.com/global/prismic/generic/rheo-knee-update-language iii. Follow the steps outlined in the application to complete the firmware update. iv. If there are any issues with completing the firmware update successfully, please contact ssur technical support at 1-800-233-6263 ext. 10. 2. PLEASE PASS THIS NOTICE to those who need to be aware within your organization. If you have further distributed this product, please identify your customers, and notify them at once of this product alert. We recommend that you include a copy of this notice. 3. PLEASE MAINTAIN AWARENESS of this notice and required actions for an appropriate period to ensure effectiveness of the corrective action.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026