BEUDAMED
    FDA Recall Terminated

    FlipCutter III Drill

    Recall: Z-1542-2020 · Initiated January 20, 2020

    Recall

    Recall Number
    Z-1542-2020
    Event Number
    85019
    Firm
    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. Kibbutz Gatton Naharia Israel
    FEI Number
    1000272060
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 20, 2020
    Terminated
    April 21, 2025

    Description

    FlipCutter III Drill

    Reason

    There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.

    Action

    Consignees are instructed to return the affected devices which will be replaced.

    Distribution

    Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.

    Quantity

    6625 units