BEUDAMED
    FDA Recall Terminated

    Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill. Imaging processing System

    Recall: Z-3184-2011 · Initiated August 4, 2011

    Recall

    Recall Number
    Z-3184-2011
    Event Number
    59797
    Firm
    Straumann Manufacturing Inc.
    FEI Number
    1000121052
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 4, 2011
    Posted
    September 13, 2011
    Terminated
    May 23, 2012
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill. Imaging processing System

    Reason

    Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.

    Action

    Staumann USA notified accounts by an Urgent Field Safety Notice letter dated August 4, 2011 and delivered via Federal Express Delivery Service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review the letter, take appropriate actions, including completing and faxing the enclosed. Customer Confirmation Form. Straumann released a corrected software upgrade (coDiagnostiX 8.0.2.3672), which is available for download when users go online and activate current software. If the user does not have internet access a replacement CD can be ordered from Technical Support at 866 - 531 -7365. Questions should be directed to Technical Support Monday through Friday from 8:00 am to 8:00 pm Eastern Time.

    Distribution

    Nationwide Distribution

    Quantity

    272