BEUDAMED
    FDA Enforcement Class II 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 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2100-2013
    Event ID
    65913
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3M Company/3m Espe Dental Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    August 5, 2013
    Classification Date
    August 27, 2013
    Termination Date
    December 11, 2013
    Address
    Bldg 0260-02a-11, Saint Paul, MN, 55144-0001, United States

    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.

    Code Info

    Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920

    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)