BEUDAMED
    FDA Enforcement Class II Terminated

    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)

    Recall: Z-2765-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2765-2016
    Event ID
    74839
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2016
    Initiation Date
    August 2, 2016
    Classification Date
    September 8, 2016
    Termination Date
    March 30, 2017
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020, United States

    Description

    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)

    Reason

    Tip Breakage at the glue joint between the obturator body and tip

    Code Info

    Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.

    Distribution

    US Nationwide Distribution

    Quantity

    1440 units