BEUDAMED
    FDA Enforcement Class II Terminated

    FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

    Recall: Z-0657-2016 · Reported January 27, 2016

    Enforcement

    Recall Number
    Z-0657-2016
    Event ID
    72697
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 27, 2016
    Initiation Date
    November 20, 2015
    Classification Date
    January 15, 2016
    Termination Date
    April 12, 2017
    Address
    325 Paramount Drive, N/A, Raynham, MA, 02767-5199, United States

    Description

    FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

    Reason

    Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

    Code Info

    Lot Number: M1505053

    Distribution

    Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.

    Quantity

    45 units