BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0351-2018 · Initiated July 7, 2017

    Recall

    Recall Number
    Z-0351-2018
    Event Number
    78777
    Firm
    Hologic, Inc.
    FEI Number
    1220984
    Product Code
    OIJ
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    July 7, 2017
    Terminated
    April 4, 2018
    Address
    36, and, Danbury, CT, 06810-7301

    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.

    Action

    Letter

    Distribution

    US and OUS

    Quantity

    12 (U.S.)