Class 2 Device Recall OSSEODOC

• Date Initiated by Firm: September 11, 2020
• Create Date: October 21, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0176-2021
• Recall Event ID: 86419
• 510(K)Number: K792159
• Product Classification: Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
• 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.
• Code Information: Model 1600407 / Catalog number 1600407-001 Serial Numbers: 16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013
• Recalling Firm/ Manufacturer: Bien-Air Surgery Sa; rue de l' ouest 2b; Le Noirmont Switzerland
• Manufacturer Reason for Recall: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
• FDA Determined 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 in Commerce: Total US = 1120 foot pedals
• Distribution: US Nationwide distribution including in the states of CA, MI and MN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ERL and Original Applicant = JEDMED INSTRUMENT CO.