BEUDAMED
    FDA Recall Open, Classified

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

    Recall: Z-1992-2026 · Initiated April 3, 2026

    Recall

    Recall Number
    Z-1992-2026
    Event Number
    98707
    Firm
    DEPUY (IRELAND) Loughbeg, Ringaskiddy Co. Cork Ireland
    FEI Number
    3002854251
    Product Code
    KRO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 3, 2026
    Posted
    April 29, 2026

    Description

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

    Reason

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

    Action

    Depuy Ireland notified consignees on about 04/03/2026 via email. Consignees were instructed to examine inventory for affected units and immediately quarantine them, arrange for the return of all affected units, and complete and return the provided Business Response Form. Consignees were also instructed to forward the notification letter to anyone within each facility that needs to be informed, notify customers if affected units were further distributed and post a copy of the notification letter in a visible area for awareness.

    Distribution

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

    Quantity

    3 units