BEUDAMED
    FDA Recall Terminated

    3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: 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-2100-2013 · Initiated August 5, 2013

    Recall

    Recall Number
    Z-2100-2013
    Event Number
    65913
    FEI Number
    3005174370
    Product Code
    ELZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 5, 2013
    Posted
    August 27, 2013
    Terminated
    December 11, 2013
    Address
    3M Company/3m, Bldg 0260-02a-11 Espe Dental Products, Saint Paul, MN, 55144-0001

    Description

    3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: 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 ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.

    Action

    3M ESPE sent a 3M "Voluntary Recall" letter dated August 1, 2013 to all affected customers. Separate letters were addressed to distributors and doctors. The letters described the product affected by the recall, problem and actions to be taken. The doctors were advised to complete the attached inventory checklist and call the 3M ESPE Dental Products Customer Care Center at 1-800-634-2249. Select option #1 to arrange for return and replacement of your product. Distributors were advised to quarantine and return the product and not to further distribute it. For product return they should contact 3M ESPE Dental Products Customer Service at 1-800-237-1650. If the product was further distributed they ask that they inform them of the recall. A letter was prepared that can be used for their communication to customers. for additional questions they should contact 651-733-7767.

    Distribution

    Worldwide Distribution - USA Nationwide in the states of CA, FL, GA, IN, IA, MO, NV, NJ, NY, PA, SC, TN, TX, WA. and the country of CANADA.

    Quantity

    3409 crowns (2949 US and 460 OUS)