Recall Z-0814-2018— Otto Bock Healthcare Product

Name: FDA recall Z-0814-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-12

Class II · Terminated

Class II FDA medical device recall by Otto Bock Healthcare Product, initiated 2017-09-12, terminated 2021-01-19. FDA's recall record names no specific 510(k) clearance for this event. Product: OTTO BOCK Kenevo knee joints Model 3C60. Reason: Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cause damage to the pylon. When used longer than 1.45 million cycles (which represents approximately 2.3 years of use of the knee joint under heavy usage conditions), AND the pylon clamp is overtightened according to the labeled torque specification, AND the patient weighs at most 125kg it may be remote that the pylon breaks, and causing the patient to fall. There have been no failures or complaints reported directly attributed to the failure mode collapsed pylon. In the US Market and in Canada, labeling requires a condition based service at three years. In the rest of the world, a mandatory two year service interval is specified. Only the devices in distribution in the United States and Canada are affected by this action..

Recalling firm: Otto Bock Healthcare Product
Classification: Class II
Status: Terminated
Initiated: 2017-09-12
Terminated: 2021-01-19
Firm location: Vienna, N/A, Austria

Product description

OTTO BOCK Kenevo knee joints Model 3C60

Reason for recall

Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cause damage to the pylon. When used longer than 1.45 million cycles (which represents approximately 2.3 years of use of the knee joint under heavy usage conditions), AND the pylon clamp is overtightened according to the labeled torque specification, AND the patient weighs at most 125kg it may be remote that the pylon breaks, and causing the patient to fall. There have been no failures or complaints reported directly attributed to the failure mode collapsed pylon. In the US Market and in Canada, labeling requires a condition based service at three years. In the rest of the world, a mandatory two year service interval is specified. Only the devices in distribution in the United States and Canada are affected by this action.

Data sourced from openFDA. This site is unofficial and independent of the FDA.