BEUDAMED
    FDA Enforcement Class II Terminated

    Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.

    Recall: Z-0205-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0205-2013
    Event ID
    63412
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    December 12, 2011
    Classification Date
    November 5, 2012
    Termination Date
    November 5, 2012
    Address
    1332 S Lone Hill Ave, N/A, Glendora, CA, 91740-5339, United States

    Description

    Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.

    Reason

    The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130¿C. The correct sterilization temperature should be listed as 132¿C and/or 270¿F.

    Code Info

    Part Numbers 601-0007 and 601-0010, all lots

    Distribution

    Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique.

    Quantity

    4,543