CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
RKNXC0003, Rheo Knee XC 3 YR Warranty, MD, CE recalled by Ossur H / F
Ossur H / F is recalling RKNXC0003, Rheo Knee XC 3 YR Warranty, MD, CE, External lower limb prosthetic component, distributed nationwide in the US. The recall was initiated on 25 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1789-2024
- FDA event ID
- 94332
- Recalling firm
- Ossur H / F, Reykjavik, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2024
- FDA classified
- 10 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 25 Mar 2024 | Recall initiated by company | |
| 10 May 2024 | Classified by FDA | +46 days |
| 22 May 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 94332This product is part of a recall event; the main page for the event is RKN130002, Rheo Knee 2 YR Warranty, MD, CE recalled by Ossur H / F.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | RKN130002, Rheo Knee 2 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide | |
| CLASS II | RKNXC0005, Rheo Knee XC 5 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide | |
| CLASS II | RKN130003, Rheo Knee 3 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
More recalls from Ossur H / F
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Miami J Select Collar recalled by Ossur H / F | Ossur H / F | Other | 39 states |
| Device | CLASS II | RKN130003, Rheo Knee 3 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | RKNXC0005, Rheo Knee XC 5 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | RKN130002, Rheo Knee 2 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | Power Knee recalled by Ossur H / F | Ossur H / F | Device Malfunction | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |