RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Summary
The FDA issued a Class II for RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic co by Ossur H / F. Reason: Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient fall.
Details
Source
Device Recall
External ID
Z-1789-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Lot/Code Info: 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
Quantity Affected: 107 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-25
Company
Reykjavik, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ossur H / F has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ossur H / F) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ossur H / F have FDA actions?
Ossur H / F has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1789-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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