BEUDAMED
    FDA Enforcement Class II Ongoing

    Everest MI XT Outer Dilator, Catalog Number 5101-90168

    Recall: Z-0706-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0706-2022
    Event ID
    89522
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    K2M, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    January 13, 2022
    Classification Date
    March 1, 2022
    Address
    600 Hope Pkwy SE, Leesburg, VA, 20175-4428, United States

    Description

    Everest MI XT Outer Dilator, Catalog Number 5101-90168

    Reason

    Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

    Code Info

    GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    686 Total Devices