BEUDAMED
    FDA Enforcement Class II Ongoing

    Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

    Recall: Z-1373-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1373-2023
    Event ID
    91800
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Coloplast Manufacturing US, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2023
    Initiation Date
    March 1, 2023
    Classification Date
    April 12, 2023
    Address
    1601 W River Rd, N/A, Minneapolis, MN, 55411-3431, United States

    Description

    Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

    Reason

    A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

    Code Info

    UDI/DI 05708932487344, Lot Numbers: 8849599, 8887865, 8939119, 8904178, 8904179

    Distribution

    Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.

    Quantity

    25 units