March 2018

Ottobock Kenovo knee joint under FDA recall

The U.S Food and Drug Administration (FDA) issued a Class 2 device recall of the Ottobock Kenovo prosthetic knee joint, model 3C60=ST and model 3C60.

According to the notice, Ottobock discovered that the pylon may break if the device is used longer than 1.45 million cycles –or approximately 2.3 years of heavy use — and the pylon clamp is tightened in excess of labeled torque specifications. Pylon breakage may cause the patient to fall. In the United States and in Canada, a 3-year service interval is required—compared to a 2-year mandatory service interval for the rest of the world—thus, only devices in the United States and Canada are affected by this recall.

Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.