BEUDAMED
    FDA Enforcement Class II Ongoing

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

    Recall: Z-1986-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-1986-2026
    Event ID
    98707
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DEPUY (IRELAND)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 6, 2026
    Initiation Date
    April 3, 2026
    Classification Date
    April 29, 2026
    Address
    Loughbeg, Ringaskiddy, Co. Cork, N/A, Ireland

    Description

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

    Reason

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Code Info

    Part Number: 150450105. UDI-DI: 10603295533122. Lot Number: AF1007829. Expiration Date: 12/31/2035.

    Distribution

    US Nationwide distribution in the states of MN, NC, TX.

    Quantity

    3 units