BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.

    Recall: Z-0222-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0222-2016
    Event ID
    72495
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2015
    Initiation Date
    September 8, 2015
    Classification Date
    November 5, 2015
    Termination Date
    January 14, 2019
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    Description

    Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.

    Reason

    The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.

    Code Info

    Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.

    Distribution

    Nationwide Distribution.

    Quantity

    41 units