BEUDAMED
    FDA Recall Terminated

    MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant.

    Recall: Z-1997-2009 · Initiated July 7, 2009

    Recall

    Recall Number
    Z-1997-2009
    Event Number
    52614
    Firm
    IMTEC Corporation
    FEI Number
    1000118617
    Product Code
    KKO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 7, 2009
    Posted
    September 10, 2009
    Terminated
    December 2, 2009
    Address
    2401 N Commerce St, Ardmore, OK, 73401-1311

    Description

    MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant.

    Reason

    Size printed on product packaging does not match size of enclosed product.

    Action

    A notification letter dated July 7, 2009 was issued to customers. The letter described the issue and instructed customers do not use the affected product and call IMTEC, a 3M Company, at 1-800-879-9799, extension 240 for assistance. Customers were further instructed to complete the enclosed Recall Response Fax-Back Form with information on their inventory (whether or not the recalled product is in their stock). The firm's representative will follow-up with customers if no response within three business days of receiving the notification letter.

    Distribution

    Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany.

    Quantity

    605 units