BEUDAMED
    FDA Recall Terminated

    Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA. Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.

    Recall: Z-0171-2010 · Initiated October 6, 2009

    Recall

    Recall Number
    Z-0171-2010
    Event Number
    53531
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    FHW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 6, 2009
    Posted
    November 10, 2009
    Terminated
    December 12, 2011
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3430

    Description

    Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA. Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.

    Reason

    Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. Coloplast is not recommending product explant because there are no identified risks since the prod

    Action

    Coloplast issued a customer notification letter dated October 2009 describing the affected product. For further information, contact Coloplast at 1-800-533-0464.

    Distribution

    Nationwide Distribution -- FL, GA, NC.

    Quantity

    3