BEUDAMED
    FDA Recall Terminated

    S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head

    Recall: Z-1703-2010 · Initiated May 14, 2010

    Recall

    Recall Number
    Z-1703-2010
    Event Number
    55744
    Firm
    3m Imtec Corporation
    FEI Number
    1000118617
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 14, 2010
    Posted
    May 27, 2010
    Terminated
    July 14, 2010
    Address
    2401 N Commerce St, Ardmore, OK, 73401-1311

    Description

    S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head

    Reason

    Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.

    Action

    IMTEC notified consignees by phone on May 14, 2010 and by Certified Letter dated May 14, 2010.

    Distribution

    Nationwide.

    Quantity

    189 Implants