BEUDAMED
    FDA Recall Terminated

    XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant)

    Recall: Z-0231-2007 · Initiated November 17, 2006

    Recall

    Recall Number
    Z-0231-2007
    Event Number
    36844
    Firm
    Dentsply Friadent Ceramed
    FEI Number
    1721411
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2006
    Posted
    December 1, 2006
    Terminated
    April 30, 2007
    Address
    12860 W Cedar Dr, Ste 101, Lakewood, CO, 80228-1965

    Description

    XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant)

    Reason

    Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.

    Action

    Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product.

    Distribution

    Worldwide-USA and one Canadian consignee.

    Quantity

    1685 units