BEUDAMED
    FDA Recall Terminated

    Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.

    Recall: Z-1538-2015 · Initiated April 9, 2015

    Recall

    Recall Number
    Z-1538-2015
    Event Number
    70960
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    FAE
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    April 9, 2015
    Posted
    April 27, 2015
    Terminated
    September 11, 2015
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3431

    Description

    Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.

    Reason

    Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.

    Action

    Consignees were notified via Field Representatives starting on 4-9-2015 with a Coloplast "Urgent Correction Notification" letter dated April 7, 2015. The letter described the problem and the product involved in the recall. Requested consignees to complete the Return Form if returning inventory. For questions contact Customer Service at 800-258-3476.

    Distribution

    Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE

    Quantity

    11 (6 USA, 5 OUS)