BEUDAMED
    FDA Enforcement Class III Ongoing

    Total Knee Pack, REF CETJ130, medical convenience kits

    Recall: Z-1973-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1973-2023
    Event ID
    92240
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 21, 2023
    Initiation Date
    April 17, 2023
    Classification Date
    June 15, 2023
    Address
    2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, 64117-2648, United States

    Description

    Total Knee Pack, REF CETJ130, medical convenience kits

    Reason

    Incorrect expiration date on product.

    Code Info

    UDI/DI: 00191072179593; Lot Number: 967231

    Distribution

    US Distribution to the state of: MA

    Quantity

    36 units