Class 2 Device Recall RHEO KNEE XC

• Date Initiated by Firm: March 25, 2024
• Date Posted: May 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1789-2024
• Recall Event ID: 94332
• Product Classification: Assembly, knee/shank/ankle/foot, external - Product Code ISW
• Product: RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
• Code Information: UDI: 05690977467804/ Serial Numbers: HF366771 HF366854 HF366819 HF363224 HF366748 HF364570 HF366805 HF364686 HF366831 HF365048 HF366880 HF365049 HF366757 HF365311 HF366787 HF365378 HF366815 HF365447 HF366826 HF365546 HF366838 HF365787 HF366874 HF365810 HF362144 HF366081 HF366755 HF366229 HF366759 HF366409 HF366778 HF366647 HF366795 HF366648 HF366811 HF366650 HF366817 HF366651 HF366823 HF366652 HF366828 HF366653 HF366836 HF366659 HF366849 HF366661 HF366860 HF366665 HF366878 HF366672 HF366893 HF366673 HF366738 HF366678 HF366754 HF366680 HF366756 HF366681 HF366758 HF366690 HF366762 HF366692 HF366775 HF366693 HF366782 HF366696 HF366793 HF366697 HF366802 HF366698 HF366806 HF366699 HF366812 HF366700 HF366816 HF366701 HF366818 HF366706 HF366821 HF366707 HF366824 HF366708 HF366827 HF366714 HF366829 HF366717 HF366834 HF366718 HF366837 HF366719 HF366839 HF366720 HF366853 HF366722 HF366859 HF366723 HF366862 HF366724 HF366875 HF366732 HF366879 HF366733 HF366884 HF366734 HF366895 HF366735 HF366737
• Recalling Firm/ Manufacturer: Ossur H / F; Grjothals 5; Reykjavik Iceland
• For Additional Information Contact: Joshua Portman; 354-515-1300
• Manufacturer Reason for Recall: 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 Determined 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 in Commerce: 107 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.