BEUDAMED
    FDA Recall Terminated

    3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

    Recall: Z-0428-2014 · Initiated June 5, 2013

    Recall

    Recall Number
    Z-0428-2014
    Event Number
    66509
    Firm
    3M Company Health Care Business 3M Center
    FEI Number
    2110898
    Product Code
    ELZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 5, 2013
    Posted
    November 27, 2013
    Terminated
    December 11, 2013
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144

    Description

    3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

    Reason

    3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns.

    Action

    3M Company sent a Voluntary Recall letterdated June 4, 2013, to all affected consignees. The letter described the problem and the product involved in the recall. Advised consignees to review their inventory and quarantine the product and do not further distribute it. For replacement they should call Customer Service at 3M ESP Dental Products at 1-800-237-1650. If they have further distributed the product they requested they contact their customers to inform them of the recall. 3M prepared a letter to be used in their communications with their customers. The customers should contact 1-800-634-2249. For questions regarding this recall call 651-733-5718.

    Distribution

    Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.

    Quantity

    1419 (1325 US, 94 OUS)