BEUDAMED
    FDA Enforcement Class II Ongoing

    Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568

    Recall: Z-0387-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0387-2024
    Event ID
    93323
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2023
    Initiation Date
    October 9, 2023
    Classification Date
    November 21, 2023
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568

    Reason

    Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

    Code Info

    Lot Numbers/UDI: 535450 (01)00880304461611(17)270727(10)535450; 577600 (01)00880304461611(17)270630(10)577600; 577610 (01)00880304461611(17)270702(10)577610; 577760 (01)00880304461611(17)270629(10)577760; 671540 (01)00880304461611(17)271124(10)671540; 671890 (01)00880304461611(17)271114(10)671890; 671890R (01)00880304461611(17)271114(10)671890R; 857060 (01)00880304461611(17)280324(10)857060; 930770 (01)00880304461611(17)270725(10)930770

    Distribution

    Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

    Quantity

    N/A