BEUDAMED
    FDA Recall Open, Classified

    Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

    Recall: Z-1367-2023 · Initiated March 1, 2023

    Recall

    Recall Number
    Z-1367-2023
    Event Number
    91800
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    FHW
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    March 1, 2023
    Posted
    April 12, 2023
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3431

    Description

    Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; 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.

    Action

    The firm issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice on 03/01/2023 by UPS next day air. The notice explained the issue and the hazard to health. The notice requests the removal and return of the affected product. Distributors are instructed to notify their customers. For further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email [email protected].

    Distribution

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

    Quantity

    15 units