BEUDAMED
    FDA Enforcement Class II Ongoing

    Coryell Memorial Hosp Total, Joint Pack - Surgical Kit

    Recall: Z-0866-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0866-2022
    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

    Coryell Memorial Hosp Total, Joint 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 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822

    Distribution

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

    Quantity

    348 units