FDA Medical Device Recalls (openFDA)
Ossur H / F: RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Recall number
- Z-1787-2024
- Recalling firm
- Ossur H / F
- Product
- RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Status
- Open, Classified
- Initiated
- 2024-03-25
- Posted
- 2024-05-10
- Terminated
- not on file
- Reason
- Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Root cause
- Software design
- Action
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- UDI: 05690967598426/ Serial Number: HF377253 1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISW
- Firm FEI
- 3003764610
- Firm city
- Reykjavik
- Firm state
- not on file
- Firm country
- Iceland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28