BEUDAMED
    FDA Enforcement Class II Ongoing

    Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

    Recall: Z-2146-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2146-2023
    Event ID
    92575
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2023
    Initiation Date
    May 18, 2023
    Classification Date
    July 14, 2023
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

    Reason

    Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.

    Code Info

    GUIDID: 04046963469054 Lot Number: 22002834

    Distribution

    US Nationwide distribution in the states of DC, MO, PA, TX.

    Quantity

    7 units