BEUDAMED
    FDA Enforcement Class II Ongoing

    28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122

    Recall: Z-0314-2022 · Reported December 8, 2021

    Enforcement

    Recall Number
    Z-0314-2022
    Event ID
    88964
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 8, 2021
    Initiation Date
    October 15, 2021
    Classification Date
    November 30, 2021
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122

    Reason

    There is a potential for the outer white Tyvek lid to debond from the sealed package.

    Code Info

    UDI number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306

    Distribution

    Puerto Rico