Ossur H / F 2024-05-22 Health serious FDA
Health · FDA · Recall #FDA-Z-1787-2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component Recall
Issued May 22, 2024 · Ossur H / F
In May 2024, Ossur H / F recalled the RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
What you should do
- 1 Stop using RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ossur H / F to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Ossur H / F
- Category
- Health
- Recall date
- May 22, 2024
- Units affected
- Not reported
- Sold at
- 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,
- Recall number
- FDA-Z-1787-2024
- Made in
- Iceland
- Issuing agency
- FDA
In context
- Ossur H / F has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.