Device 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.
Z-1322-2015
Product summary
- Firm
- Ossur H / F
- Event
- Event 70693
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4715 units (2 units affected)
- Official record key
device-enforcement:Z-1322-2015
Official wording
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.
Code information: Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498
Distribution pattern: Worldwide distribution: US distribution in TN and country of: Austria.
Derived failure modes
-
Unknown
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.