BEUDAMED
    FDA Recall Terminated

    Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10

    Recall: Z-1592-2011 · Initiated September 30, 2010

    Recall

    Recall Number
    Z-1592-2011
    Event Number
    56994
    Firm
    Straumann Manufacturing Inc.
    FEI Number
    1000121052
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 30, 2010
    Posted
    March 7, 2011
    Terminated
    September 19, 2011
    Address
    60 Minuteman Rd, Andover, MA, 01810

    Description

    Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10

    Reason

    Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.

    Action

    Straumann notified accounts of this correction by letter dated September 30, 2010 and delivered via Federal Express Delivery Service. The upgrade is available on-line by logging into the coDiagnostiX system and enabling the automatic upgrade to occur.

    Distribution

    Nationwide

    Quantity

    20 systems