BEUDAMED
    FDA Enforcement Class II Terminated

    Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880

    Recall: Z-0351-2018 · Reported January 24, 2018

    Enforcement

    Recall Number
    Z-0351-2018
    Event ID
    78777
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2018
    Initiation Date
    July 7, 2017
    Classification Date
    January 14, 2018
    Termination Date
    April 4, 2018
    Address
    36 and 37 Apple Ridge Rd, N/A, Danbury, CT, 06810-7301, United States

    Description

    Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880

    Reason

    The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.

    Code Info

    UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165

    Distribution

    US and OUS

    Quantity

    12 (U.S.)