U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
The firm, Ossur, notified their customers of the Recall Notice via phone on February 26, 2015. The firm informed the customers about the recalled product, the problem and actions to be taken. The customers were instructed to send the unit in for service so the Acceptance testing can be performed for the unit in accordance to their process.
If you have any questions, please contact Regulatory Affairs & Quality Assurance specialist at 949-382-3741 or email: kmontes@ossur.com.
Worldwide distribution: US distribution in TN and country of: Austria.
제품 설명
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.