BEUDAMED
    FDA Enforcement Class II Terminated

    Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544

    Recall: Z-2516-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2516-2021
    Event ID
    88325
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    March 19, 2021
    Classification Date
    September 22, 2021
    Termination Date
    March 28, 2025
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544

    Reason

    Malfunction- loosening of the implant resulting in a potential revision surgery

    Code Info

    All lots

    Distribution

    US Nationwide distribution.