Devices

Device Recall Rheo Knee

Model / Serial
Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498
Product Classification
Physical Medicine Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US distribution in TN and country of: Austria.
Product 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.
Manufacturer
Ossur H / F
1 Event
- Recall of Device Recall Rheo Knee

Manufacturer

Ossur H / F

Manufacturer Address
Ossur H / F, Grjothals 5, Reykjavik Iceland
Manufacturer Parent Company (2017)
Össur hf
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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