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U.S. Department of Health and Human Services

Class 2 Device Recall RHEO KNEE

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 Class 2 Device Recall RHEO KNEEsee related information
Date Initiated by FirmMarch 25, 2024
Date PostedMay 10, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1787-2024
Recall Event ID 94332
Product Classification Assembly, knee/shank/ankle/foot, external - Product Code ISW
ProductRKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Code Information UDI: 05690967598426/ Serial Number: HF377253 1
Recalling Firm/
Manufacturer		 Ossur H / F
Grjothals 5
Reykjavik Iceland
For Additional Information ContactJoshua 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 2		Software design
ActionOn 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.
DistributionUS 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 CycleTPLC 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.
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