BEUDAMED
    FDA Recall Terminated

    AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451

    Recall: Z-0931-04 · Initiated April 29, 2004

    Recall

    Recall Number
    Z-0931-04
    Event Number
    28972
    Firm
    American Medical Systems
    FEI Number
    1000116179
    Product Code
    JCW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 29, 2004
    Terminated
    October 31, 2005
    Address
    10700 Bren Rd, W Minnetonka, MN, 55343-9679

    Description

    AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451

    Reason

    The product is mislabeled as to length.

    Action

    Recall letters, dated April 29, 2004, state that it is important for the consignees to contact the firm's customer service for an exchange of the recalled products for new product. The letters recommend that the consignees send an attached letter to physicians who implanted the products.

    Distribution

    The affected products were distributed to consignees in the States of California and Texas, in Puerto Rico, and in the countries of Costa Rica and Taiwan.

    Quantity

    5 units