The Recall Desk

FDA (Devices) recall action 86419

Bien-Air Surgery Sa recalled 5 products on 2020-10-28

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2020-10-28
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–5 of 5

  • SevereFDA (Devices)··2020-10-28

    Entellus Medical Shaver System Foot Pedal Recalled for Magnet Defect

    Bien-Air Surgery Sa is recalling Entellus Medical Shaver System foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2020-10-28

    Stryker S2 Mini Foot Pedal Recalled Due to Magnet Defect

    Bien-Air Surgery is recalling Stryker S2 Mini Foot Pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot ped
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2020-10-28

    Bien-Air Surgery Foot Pedal Recalled Due to Magnet Detachment Risk

    Bien-Air Surgery is recalling 1,120 foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    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.
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2020-10-28

    Bien-Air Surgery OSSEOSTAP Footcontrol Recalled for Magnet Defect

    Bien-Air Surgery is recalling OSSEOSTAP foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    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.
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2020-10-28

    Bien-Air Surgery Multifunction Pedal Recalled Due to Magnet Failure Risk

    Bien-Air Surgery is recalling 1,120 OsseoDuo multifunction foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spi
    Category
    Distribution
    4 states