BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.

    Recall: Z-0855-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0855-2016
    Event ID
    73042
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    December 23, 2015
    Classification Date
    February 23, 2016
    Termination Date
    May 19, 2017
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.

    Reason

    The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided.

    Code Info

    All lots of the following Catalog Numbers: 2704-1-024; 2704-3-018; 6703-1-018; 6703-2-120; 6704-1-018; 6704-2-120 and 6704-3-120.

    Distribution

    Nationwide Distribution.

    Quantity

    3,741 units