BEUDAMED
    FDA Recall Terminated

    AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Pump, 2 Cylinders.

    Recall: Z-0787-2007 · Initiated February 9, 2007

    Recall

    Recall Number
    Z-0787-2007
    Event Number
    37437
    Firm
    American Medical Systems
    FEI Number
    1000116179
    Product Code
    JCW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2007
    Posted
    May 9, 2007
    Terminated
    February 24, 2008
    Address
    10700 Bren Rd, W Minnetonka, MN, 55343-9679

    Description

    AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Pump, 2 Cylinders.

    Reason

    The carton labeling does not match the product packaged inside.

    Action

    AMS has contacted every account (via e-mail 2/9/2007) that either purchased or implanted the affected product. Unused pieces have been recovered and scrapped.

    Distribution

    Worldwide, including USA, Canada and England.

    Quantity

    1