BEUDAMED
    FDA Enforcement Class II Terminated

    NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.

    Recall: Z-0591-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0591-2018
    Event ID
    79042
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 21, 2018
    Initiation Date
    August 10, 2017
    Classification Date
    February 12, 2018
    Termination Date
    August 8, 2018
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.

    Reason

    The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.

    Code Info

    The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).

    Distribution

    USA (nationwide)

    Quantity

    13 Units