Class 2 Device Recall OSSEODUO

• Date Initiated by Firm: September 11, 2020
• Create Date: October 21, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0177-2021
• Recall Event ID: 86419
• 510(K)Number: K083720
• Product Classification: Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
• 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 spine and cranium.
• Code Information: Model 1600517 / Catalog number 1600517-001 Serial Numbers: 18F0017 18F0030 18G0003 18G0018 18G0019 18G0020 18G0021 18G0025 18H0016 18H0017 18H0018 18H0019 18H0026 18H0027 18I0003 18I0004 18I0005 18I0006 18I0018 18I0022 18I0023 18I0024 18I0025 18I0026 18I0027 18I0028 18I0029 18I0030 18J0001 18J0002 18J0003 18J0004 18J0005 18J0009 18J0010 18J0011 18J0012 18J0013 18J0014 18J0015 18J0016 18J0017 18J0018 18J0019 18J0020 18J0021 18J0022 18J0023 18J0024 18J0025 18J0026 18J0037 18J0038 18J0039 18J0040 18J0041 18L0012 18L0014 18L0017 18L0018 18L0019 18L0020 18L0021 18L0023 19B0021 19B0022 19B0023 19B0024 19B0025 19B0028 19B0029 19B0030 19B0038 19B0041 19B0042 19B0043 19B0044 19B0051 19B0052 19B0053 19B0054 19B0055 19B0056 19B0058 19B0059 19E0004 19E0005 19E0008 19E0009 19E0011 19E0012 19E0013 19E0014 19E0015 19E0016 19E0017 19E0028 19E0029 19E0030 19E0035 19E0037 19E0047 19E0048 19E0053 19E0054 19E0055 19E0056 19E0057 19E0058 19E0060 19E0063 19E0064 19E0068 19E0069 16A0015 16A0016 16G0024 16I0007 16I0026 16I0027 16I0028 16I0029 16K0027 17A0009 17B0008 17B0009 17B0010 17B0011 17B0012 17B0013 17B0039 17B0040 17B0041 17B0049 17B0050 17C0012 17C0013 17E0033 17G0004 17G0024 17G0025 19E0006 19E0007 19E0010
• 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 = BIEN-AIR SURGERY SA