BEUDAMED
    FDA Enforcement Class II Ongoing

    Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.

    Recall: Z-0178-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0178-2021
    Event ID
    86419
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bien-Air Surgery Sa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 28, 2020
    Initiation Date
    September 11, 2020
    Classification Date
    October 21, 2020
    Address
    rue de l' ouest 2b, N/A, Le Noirmont, N/A, N/A, Switzerland

    Description

    Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.

    Reason

    The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

    Code Info

    Model 1600686 / Catalog number 1600686-001 Serial Numbers: 18D0006 18D0007 18D0008 18D0009 18D0010 18D0013 18D0014 18D0015 18D0016 18D0017 18D0018 18D0019 18D0020 18D0021 18D0022 18D0023 18D0024 18D0025 18D0026 18D0027 18D0028 18D0029 18D0030 16A0005 16A0009 16A0010 16A0011 16A0014 17D0011 17G0006

    Distribution

    US Nationwide distribution including in the states of CA, MI and MN.

    Quantity

    Total US = 1120 foot pedals