BEUDAMED
    FDA Enforcement Class II Ongoing

    Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

    Recall: Z-0176-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0176-2021
    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 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

    Reason

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

    Code Info

    Model 1600407 / Catalog number 1600407-001 Serial Numbers: 16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013

    Distribution

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

    Quantity

    Total US = 1120 foot pedals