BEUDAMED
    FDA Enforcement Class II Ongoing

    SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001

    Recall: Z-1208-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1208-2023
    Event ID
    91601
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Coltene Whaledent Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 8, 2023
    Initiation Date
    January 20, 2023
    Classification Date
    March 2, 2023
    Address
    235 Ascot Pkwy, N/A, Cuyahoga Falls, OH, 44223-3701, United States

    Description

    SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001

    Reason

    Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button

    Code Info

    UDI-DI: +ESANS100010 All Serial Numbers

    Distribution

    Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey

    Quantity

    3896 units