Recall Z-1322-2015— Ossur H / F
Class II · Terminated
Class II FDA medical device recall by Ossur H / F, initiated 2015-02-26, terminated 2015-11-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Ossur H / F
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-26
- Terminated
- 2015-11-20
- Firm location
- Reykjavik, Iceland
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.