Reported May 22, 2024 · Ongoing
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Ossur H / F
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ossur H / F · Grjothals 5 · Reykjavik, N/A · N/A
Is this the product you have?
- RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Lot codes and dates
- UDI05690967595418/
- Serial Numbers
143 of 143 codes
HF383471HF383327HF383283HF366857HF383410HF375146HF365047HF375188HF383312HF375583HF383377HF376371HF383431HF376550HF383493HF376791HF383276HF377332HF383294HF377766HF383319HF378019HF383346HF378063HF383387HF378251HF383419HF378272HF383437HF378504HF383485HF378508HF383506HF378541HF383273HF378957HF383281HF379043HF383291HF379062HF383310HF379277HF383315HF379328HF383321HF379484HF383342HF380010HF383355HF380230HF383384HF380398HF383395HF380403HF383412HF380450HF383426HF380510HF383434HF381405
- Amount recalled
- 143 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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