BEUDAMED
    FDA Recall Terminated

    OTTO BOCK Kenevo knee joints Model 3C60

    Recall: Z-0814-2018 · Initiated September 12, 2017

    Recall

    Recall Number
    Z-0814-2018
    Event Number
    79019
    Firm
    Otto Bock Healthcare Product Brehmstrase 16 Vienna Austria
    FEI Number
    3005190268
    Product Code
    ISY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 12, 2017
    Terminated
    January 19, 2021

    Description

    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.

    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

    Distribution

    AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU

    Quantity

    75 units