BEUDAMED
    FDA Recall Terminated

    Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.

    Recall: Z-0362-2007 · Initiated December 15, 2006

    Recall

    Recall Number
    Z-0362-2007
    Event Number
    37071
    Firm
    Suros Surgical Systems Inc.
    FEI Number
    3003862400
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2006
    Posted
    January 23, 2007
    Terminated
    May 4, 2007
    Address
    6100 Technology Center Dr, Indianapolis, IN, 46278-6016

    Description

    Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.

    Reason

    The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.

    Action

    Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06.

    Distribution

    Nationwide.

    Quantity

    1249 handpieces