BEUDAMED
    FDA Recall Open, Classified

    3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile

    Recall: Z-1510-2022 · Initiated May 17, 2022

    Recall

    Recall Number
    Z-1510-2022
    Event Number
    90672
    Firm
    Medical Modeling, Inc.
    FEI Number
    3003142829
    Product Code
    DZJ
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    May 17, 2022
    Address
    5381 S Alkire Cir, Littleton, CO, 80127-1403

    Description

    3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile

    Reason

    Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

    Action

    On May 17, 2022, Medical Modeling - A 3D systems Company representative contacted affected customer via phone and informed the consignee of the issue and their plan to remove the device and provide a new one.

    Distribution

    International distribution in the country of Germany.

    Quantity

    1 unit