The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498
- 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:
- The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
Product Codes/Lot Numbers:
Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498
Distribution:
Distributed in: US, TN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1322-2015
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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.