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Ossur H / F recalls The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses A
Recalled April 1, 2015 · FDA recall Z-1322-2015 · Ossur H / F
Hazard
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. · FDA Class II
Units
4715 units (2 units affected)
Sold at
Worldwide distribution: US distribution in TN and country of: Austria.
Description
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.
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.
Manufacturer(s)
Ossur H / F
Made in
Iceland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →