BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1522-2013 · Reported June 19, 2013

    Enforcement

    Recall Number
    Z-1522-2013
    Event ID
    65283
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dental EZ Stardental Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 19, 2013
    Initiation Date
    May 28, 2013
    Classification Date
    June 7, 2013
    Termination Date
    March 18, 2014
    Address
    1816 Colonial Village Ln, N/A, Lancaster, PA, 17601-5891, United States

    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.

    Code Info

    Item 200169, lot numbers 2140459 and 2177284; Item 200174, lot numbers 2151776 and 2158861; Item 200276, lot number 2149190; Item 200288, lot number 2143968; Item 200329, lot number 2139572; Item 200339, lot number 2159105; Item 200354, lot number 2149191; Item 200394, lot number 2164110; Item 200402, lot numbers 2143162 and 2156621; Item 200415, lot number 2139573; Item 200418, lot numbers 2153439, 2163438, 2166502, 2171448, 2173003, and 2175575; Item 200433, lot numbers 2153440 and 2171670; Item 200448, lot numbers 2139574, 2157306, and 2167344; Item 200468, lot number 2151894; Item 200473, lot numbers 2146257, 2156268, and 2166207; Item 200483, lot numbers 2141173, 2151723, and 2161240; Item 200496, lot numbers 2144739, 2151899, 2157307 and 2166208.

    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