BEUDAMED
    FDA Recall Terminated

    StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

    Recall: Z-1522-2013 · Initiated May 28, 2013

    Recall

    Recall Number
    Z-1522-2013
    Event Number
    65283
    Firm
    Dental EZ Stardental Division
    FEI Number
    2520265
    Product Code
    NME
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    May 28, 2013
    Posted
    June 7, 2013
    Terminated
    March 18, 2014
    Address
    1816 Colonial Village Ln, Lancaster, PA, 17601-5891

    Description

    StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

    Reason

    Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.

    Action

    Dental EZ Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter on May 28, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 866-383-4636 ext.4350 for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan.

    Quantity

    3,560