BEUDAMED
    FDA Enforcement Class II Ongoing

    Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

    Recall: Z-0645-2022 · Reported February 23, 2022

    Enforcement

    Recall Number
    Z-0645-2022
    Event ID
    89456
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 23, 2022
    Initiation Date
    December 21, 2021
    Classification Date
    February 16, 2022
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

    Reason

    There is a potential for the outer Tyvek lid to de-bond from the sealed package.

    Code Info

    UDI: 07613327013306; Lot Number: 87458602

    Distribution

    Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.

    Quantity

    1 unit