BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

    Recall: Z-2744-2015 · Reported September 16, 2015

    Enforcement

    Recall Number
    Z-2744-2015
    Event ID
    71940
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Spine, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    September 16, 2015
    Initiation Date
    August 5, 2015
    Classification Date
    September 9, 2015
    Termination Date
    February 10, 2016
    Address
    310 Interlocken Pkwy Ste 120, N/A, Broomfield, CO, 80021-3464, United States

    Description

    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

    Reason

    Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.

    Code Info

    Model Number 14-521614B, lot number 375440.

    Distribution

    Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.

    Quantity

    7 parts