BEUDAMED
    FDA Enforcement Class II Ongoing

    Anterior Hip Pack - Surgical Kit

    Recall: Z-0865-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0865-2022
    Event ID
    89671
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stradis Medical, LLC dba Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    February 25, 2022
    Classification Date
    April 4, 2022
    Address
    3025 Northwoods Pkwy, Peachtree Corners, GA, 30071-1524, United States

    Description

    Anterior Hip Pack - Surgical Kit

    Reason

    The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

    Code Info

    SKU/Part Number 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943

    Distribution

    US Nationwide distribution in the states of IN, TX, and PA.

    Quantity

    100 units