CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
RKN130002, Rheo Knee 2 YR Warranty, MD, CE recalled by Ossur H / F
Ossur H / F is recalling RKN130002, Rheo Knee 2 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-1787-2024
- 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
RKN130002, RHEO KNEE 2 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
Is RKN130002, Rheo Knee 2 YR Warranty, MD, CE, External lower limb prosthetic component recalled?
Yes. Ossur H / F recalled RKN130002, Rheo Knee 2 YR Warranty, MD, CE, External lower limb prosthetic component on 25 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1787-2024.
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: 05690967598426/ Serial Number: HF377253 1
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Lead & Heavy Metals | 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 | RKNXC0003, Rheo Knee XC 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 | Power Knee recalled by Ossur H / F | Ossur H / F | Lead & Heavy Metals | 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 | Nitrosamine Impurity | 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) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |