BEUDAMED
    FDA Enforcement Class II Ongoing

    LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11

    Recall: Z-2066-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2066-2023
    Event ID
    92496
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 12, 2023
    Initiation Date
    December 23, 2022
    Classification Date
    July 3, 2023
    Address
    Oststr. 4-10, N/A, Norderstedt, N/A, N/A, Germany

    Description

    LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11

    Reason

    Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

    Code Info

    UDI-DI: 04026575257379 Lot Number: 2123225

    Distribution

    US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.

    Quantity

    20 units