BEUDAMED
    FDA Recall Terminated

    ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.

    Recall: Z-1160-06 · Initiated May 25, 2006

    Recall

    Recall Number
    Z-1160-06
    Event Number
    35552
    Firm
    Suros Surgical Systems Inc.
    FEI Number
    3003862400
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 25, 2006
    Posted
    June 22, 2006
    Terminated
    March 12, 2007
    Address
    6100 Technology Center Dr, Indianapolis, IN, 46278-6016

    Description

    ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.

    Reason

    Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).

    Action

    Consignees were notified telephone and letter dated 5/25/06 to stop using the recalled product and to return it to the firm. The recall was extended to an additional lot by phone calls to each customer between Julne 26 and 30, 2006 and by letter dated 6/19/06 and sent between June 28 and July 7, 2006.

    Distribution

    Nationwide.

    Quantity

    939