BEUDAMED
    FDA Enforcement Class II Ongoing

    Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis

    Recall: Z-1362-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1362-2023
    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 Touch NB Infr Zero 18cm, Catalog Number EN28182400; 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 05708932072526, Lot Numbers: 8849570, 8904168, 8939114

    Distribution

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

    Quantity

    7 units