RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 05690967598426/ Serial Number: HF377253 1
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ossur H / F
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Product Codes/Lot Numbers:
UDI: 05690967598426/ Serial Number: HF377253 1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1787-2024
Related Recalls
Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.