BEUDAMED
    FDA Recall Terminated

    3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.

    Recall: Z-0800-2007 · Initiated February 12, 2007

    Recall

    Recall Number
    Z-0800-2007
    Event Number
    37635
    Firm
    3M Espe Dental Products
    FEI Number
    2020493
    Product Code
    EBF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 12, 2007
    Posted
    May 11, 2007
    Terminated
    February 24, 2008
    Address
    2111 Mcgaw Ave, Irvine, CA, 92614-0908

    Description

    3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.

    Reason

    Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.

    Action

    All consignees including distributors were notified of the recall via telephone or mail on 2/27/2007. Communication with distributors included the product being recalled, the problem , recommended stop usage or distribution and directions for return shippment. Further, the consignees were also sent a letter which described the product and problem and what to do if the product was still availabe or had been used.

    Distribution

    Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia.

    Quantity

    99