BEUDAMED
    FDA Enforcement Class II Terminated

    MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.

    Recall: Z-0203-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0203-2016
    Event ID
    72312
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Spine, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2015
    Initiation Date
    September 29, 2015
    Classification Date
    November 3, 2015
    Termination Date
    April 29, 2016
    Address
    310 Interlocken Pkwy Ste 120, N/A, Broomfield, CO, 80021-3464, United States

    Description

    MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.

    Reason

    The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.

    Code Info

    P/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550

    Distribution

    US Distribution to the states of : NY, MO, and FL

    Quantity

    17 units