BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated January 20, 2023

    Recall

    Recall Number
    Z-1208-2023
    Event Number
    91601
    Firm
    Coltene Whaledent Inc
    FEI Number
    2416455
    Product Code
    EFB
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    January 20, 2023
    Posted
    March 2, 2023
    Address
    235 Ascot Pkwy, Cuyahoga Falls, OH, 44223-3701

    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

    Action

    Coltene issued Urgent Medical Device Correction to Distributors. The written notification included the Field Safety Notice issued by the manufacturer and the Correction Notice that was issued on January 20th, 202 via Email. Letter states reason for notification, health risk, and action to take: Warning: When using the STATIS SL turbines with REF 2.000.7300 / S10001, with the lack of care or age-related wear and tear, there is a possibility that the push button on the turbine will come loose and this will increase the risk of swallowing or inhaling part of the turbines head or the push button. Recommended action for users: Please urgently observe the following safety instructions from the instructions for use on handling, care and running behaviour of the turbine to protect your patients. This notice needs to be passed on to all those who need to be aware, both within your own organization and in organizations where the potentially affected devices have been transferred. Please ensure that this information and the associated action are followed for a reasonable period of time to ensure the effectiveness of the action.

    Distribution

    Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey

    Quantity

    3896 units