BEUDAMED
    FDA Enforcement Class II Terminated

    Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.

    Recall: Z-1351-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1351-2018
    Event ID
    79533
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    W & H DentalWerk Burmoos GMBH - Site 1
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 18, 2018
    Initiation Date
    December 21, 2017
    Classification Date
    April 10, 2018
    Termination Date
    June 7, 2019
    Address
    Ignaz-Glaser-Strasse 53, Burmoos, N/A, Austria

    Description

    Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.

    Reason

    During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control might not switch back to zero position when the pedal is released. Consequently, the motor keeps rotating. If this happens during automatic thread cutting or automatic screwing-in of implants, it may, in the worst case, lead to a serious injury of the patient.

    Code Info

    REF: 05046200 05046200 05046211 05046210 06202400 06202400 30285000 30285001 Serial number "SN" from to (including) 22400 23429 E02201 E02485 E01011 E01033 E01035 E01071 24315 34040 E01358 E01658 01001 02318

    Distribution

    US Nationwide Distribution