BEUDAMED
    FDA Recall Terminated

    SPI EASY Abutment. Endosseous dental implant abutment.

    Recall: Z-1086-2007 · Initiated April 19, 2007

    Recall

    Recall Number
    Z-1086-2007
    Event Number
    38267
    Firm
    Thommen Medical, AG Hauptstrasse, 87 Waldenburg Switzerland
    FEI Number
    3003836985
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 19, 2007
    Posted
    July 24, 2007
    Terminated
    May 12, 2008

    Description

    SPI EASY Abutment. Endosseous dental implant abutment.

    Reason

    The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.

    Action

    Letter 5/14/2007. Customers are requested to check their current inventory for the recall product. If found they are to return the product for replacement. If they have implanted the product they are to check patient x-rays for the defect. If defects are found they are to do a restoration.

    Distribution

    Nationwide.

    Quantity

    84