BEUDAMED
    FDA Enforcement Class II Ongoing

    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00

    Recall: Z-2347-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2347-2023
    Event ID
    92758
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 16, 2023
    Initiation Date
    July 3, 2023
    Classification Date
    August 4, 2023
    Address
    Oststr. 4-10, N/A, Norderstedt, N/A, N/A, Germany

    Description

    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00

    Reason

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Code Info

    UDI-DI: 04026575182107 Lot Numbers: B923003 B932050 C005075 C211010

    Distribution

    US Nationwide distribution.

    Quantity

    24 units