BEUDAMED
    FDA Recall Terminated

    RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560

    Recall: Z-0975-05 · Initiated June 6, 2005

    Recall

    Recall Number
    Z-0975-05
    Event Number
    32354
    Firm
    Straumann Manufacturing Inc
    FEI Number
    1000121052
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2005
    Posted
    July 7, 2005
    Terminated
    November 3, 2005
    Address
    60 Minuteman Rd, Andover, MA, 01810

    Description

    RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560

    Reason

    Basal screw is too short to adequately hold the dental abutment in the implant

    Action

    Straumann USA initiated the recall by letter dated 6/6/05. Users are requested to return devices and to examine patients with the implanted device.

    Distribution

    AZ, CA, DE, FL, NY, OH, OK, TX

    Quantity

    23