BEUDAMED
    FDA Recall Terminated

    SICAT IMPLANT V2.0

    Recall: Z-2951-2020 · Initiated July 15, 2020

    Recall

    Recall Number
    Z-2951-2020
    Event Number
    86165
    Firm
    SICAT GMBH & CO. KG Brunnenallee
    FEI Number
    3006098230
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 15, 2020
    Terminated
    January 3, 2024
    Address
    6 Bonn Germany

    Description

    SICAT IMPLANT V2.0

    Reason

    A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.

    Action

    On 07/15/2020 customer notification letter was sent to all users/customers who have the 2.0 version of the software installed in the system. These users are instructed to only use the system for specific cases as defined in the field safety notice. The firm plans on implementing a new software version in July 2020 to correct the issues found.

    Distribution

    Worldwide distribution

    Quantity

    853 units