BEUDAMED
    FDA Enforcement Class II Ongoing

    Total Hip Kit, REF DYNJ903275S; surgical convenience kit

    Recall: Z-2366-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2366-2023
    Event ID
    92736
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 16, 2023
    Initiation Date
    July 3, 2023
    Classification Date
    August 10, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Total Hip Kit, REF DYNJ903275S; surgical convenience kit

    Reason

    The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.

    Code Info

    UDI/DI: 10195327254582 (unit), 40195327254583 (case); Lot code 23CDC733

    Distribution

    US Nationwide distribution in the state of Illinois.

    Quantity

    16 kits