Bien-Air Surgery Sa: 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 number

Z-0178-2021

Recalling firm

Bien-Air Surgery Sa

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.

Status

Open, Classified

Initiated

2020-09-11

Posted

not on file

Terminated

not on file

Reason

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

Root cause

Process control

Action

On 09/14/2020, the firm send out an "URGENT: Medical Device Correction" notification informing customer of the potential for the magnet located inside the foot pedal displaces or comes off during a surgery and therefore may compromise the device's safety. The use of the incriminated devices may entail a risk of unattended start or unstoppable motor when acting on the foot pedal. The Recalling Firm is informing customers of a curative and a corrective action to prevent the magnet from coming off: -Curative Action: 1) Inspect your inventory for the product numbers/serial numbers above. 2) Quarantine any of the affected products until performing the following actions 3) Open the foot pedal rocker to have access to the incriminated magnet by pulling the black part 4) Carefully inspect the position of the magnet using illustrations provided in the Customer Notification If the magnet is partially or full off, Customers are instructed to keep the foot pedals in quarantine (Do Not Use It Anymore), and contact the Recalling Firm's repair center and send the foot pedal back for repair. 5) If the magnet is well position, then carefully clean the plastic area around the magnet with a disinfectant wipe (e.g. alcoholic solution) and a swab to correctly clean the corners 6) Make sure the surface is clean and dry before applying an adhesive tape (e.g. Scotch, width between 10-15mm, length between 55-60mm) as described in the illustrations provide in the Customer Notification THE FOLLOWING ACTIONS MUST BE PERFORMED BEFORE EACH SURGERY 7) Carefully inspect that the adhesive tape is correctly holding the magnet. If needed, remove the tape and restart the process from step 4. 8) Close the foot pedal rocker, connect the foot pedal cable to the control unit and switch it ON 9) Proceed with the following tests before performing the surgery a. Select one motor (BASCH, 80K, NANO, RAPIDO) or one handpiece (S120, OSSEOSTAP, PERFO) depending on your needs b. Hold the motor

Quantity

Total US = 1120 foot pedals

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K143492"]

PMA numbers

not on file

Product code

ERL

Firm FEI

3003800209

Firm city

Le Noirmont

Firm state

not on file

Firm country

Switzerland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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