BEUDAMED
    FDA Enforcement Class II Ongoing

    LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

    Recall: Z-2445-2024 · Reported July 31, 2024

    Enforcement

    Recall Number
    Z-2445-2024
    Event ID
    94926
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LINK BIO CORP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 31, 2024
    Initiation Date
    June 27, 2024
    Classification Date
    July 25, 2024
    Address
    69 King St Ste 2, Dover, NJ, 07801-2800, United States

    Description

    LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

    Reason

    The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.

    Code Info

    Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.

    Distribution

    US Nationwide distribution in the states of FL, GA, KS, OH, WI.

    Quantity

    8 units