Rheo Knee recallZ-1790-2024 · Ossur H / F · initiated Mar 25, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ossur H / F or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1790-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 25, 2024
- Posted by the FDA
- May 10, 2024
- Recalling firm
- Ossur H / F
- Quantity
- 1 unit
- Product code
- ISW
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.
Product description
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
Code information (models, lots, serial numbers)
UDI: 05690977467811/ Serial Number: HF363264
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Rheo Knee RKNXC0005Ossur Americas, Inc. · Joint, Knee, External Limb Component1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94332).
- Z-1787-2024 · Open, ClassifiedRKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Z-1788-2024 · Open, ClassifiedRKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Z-1789-2024 · Open, ClassifiedRKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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