RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ossur H / F
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1789-2024
Related Recalls
Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.