BEUDAMED
    FDA Enforcement Class II Terminated

    Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

    Recall: Z-0833-2019 · Reported February 20, 2019

    Enforcement

    Recall Number
    Z-0833-2019
    Event ID
    81967
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Signature Orthopedics Pty Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 20, 2019
    Initiation Date
    December 10, 2018
    Classification Date
    February 14, 2019
    Termination Date
    December 14, 2020
    Address
    Lane Cove W, 7 Sirius Rd, Lane Cove West, N/A, N/A, Australia

    Description

    Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

    Reason

    Product mix up

    Code Info

    UDI # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F

    Distribution

    US Nationwide Distribution in the states of FL, NY, and TN

    Quantity

    10