OTTO BOCK Kenevo knee joints 의 리콜

Recall

79019

Class 2

Z-0815-2018

2017-09-12

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161206

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.

On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service. Customer Service: (800) 328-3458  Option 1 Loaner Service: (800) 328-3458  Option 3, then Option 1