Ossur H / F recalls The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses A…

Recall date

February 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1322-2015

FDA classification

Class II

Brand / firm

Ossur H / F

Sold / distributed

Worldwide distribution: US distribution in TN and country of: Austria.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.