BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0205-2013 · Initiated December 12, 2011

    Recall

    Recall Number
    Z-0205-2013
    Event Number
    63412
    Firm
    Ormco/Sybronendo
    FEI Number
    2016150
    Product Code
    DZN
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    December 12, 2011
    Posted
    November 5, 2012
    Terminated
    November 5, 2012
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    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 130C. The correct sterilization temperature should be listed as 132C and/or 270F.

    Action

    "Urgent - Medical Device Correction" letters dated 12/12/2011 were sent via USPS 1st class mail to all customers and again on 2/21/2012 for recall expansion. The device issue was described and recommended actions were provided. Customers were instructed to acknowledge and complete the Return Form. Questions were referred to (800) 854-1741.

    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