Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model 1600998 / Catalog number 1600998-001 Serial Numbers: 17K0059 19A0042 16H0001 16H0002 16H0003 16H0004 16H0005 16H0006 16H0007 16H0008 16H0009 16H0010 16H0011 16H0012 16H0013 16H0014 16H0015 16H0016 16H0017 16H0018 16H0019 16H0020 16H0021 16H0022 16H0023 16H0024 16H0025 16J0001 16J0002 16J0003 16J0004 16J0005 16J0006 16J0007 16J0008 16J0009 16J0010 16J0011 16J0012 16J0013 16J0014 16J0015 16J0016 16J0017 16J0018 16J0019 16J0020 16J0021 16J0022 16J0023 16J0024 16J0025 16J0026 16J0027 16J0028 16J0029 16J0030 16L0001 16L0002 16L0003 16L0004 16L0005 16L0006 16L0007 16L0008 16L0009 16L0010 16L0011 16L0012 16L0013 16L0014 16L0015 16L0016 16L0017 16L0018 16L0019 16L0020 16L0021 16L0022 16L0023 16L0024 16L0025 16L0026 16L0027 16L0028 16L0029 16L0030 17A0001 17A0002 17A0003 17A0004 17A0005 17A0006 17A0007 17A0008 17A0009 17A0010 17A0011 17A0012 17A0013 17A0014 17A0015 17A0016 17A0017 17A0018 17A0019 17A0020 17A0021 17A0022 17A0023 17A0024 17A0025 17A0026 17A0027 17A0028 17A0029 17A0030 17C0001 17C0002 17C0003 17C0004 17C0005 17C0006 17C0007 17C0008 17C0009 17C0010 17C0011 17C0012 17C0013 17C0014 17C0015 17C0016 17C0017 17C0018 17C0019 17C0020 17C0021 17C0022 17C0023 17C0024 17C0025 17C0026 17C0027 17C0028 17C0029 17C0030 17D0001 17D0002 17D0003 17D0004 17D0005 17D0006 17D0007 17D0008 17D0009 17D0010 17D0011 17D0012 17D0013 17D0014 17D0015 17D0016 17D0017 17D0018 17D0019 17D0020 17D0021 17D0022 17D0023 17D0024 17D0025 17D0026 17D0027 17D0028 17D0029 17D0030 17E0001 17E0002 17E0003 17E0004 17E0005 17E0006 17E0007 17E0008 17E0009 17E0010 17E0011 17E0012 17E0013 17E0014 17E0015 17E0016 17E0017 17E0018 17E0019 17E0020 17E0021 17E0022 17E0023 17E0024 17E0025 17E0026 17F0001 17F0002 17F0003 17F0004 17F0005 17F0006 17F0007 17F0008 17F0009 17F0010 17F0011 17F0012 17F0013 17F0014 17F0015 17F0016 17F0017 17F0018 17F0019 17F0020 17F0021 17F0022 17G0001 17G0002 17G0003 17G0004 17G0005 17G0006 17G0007 17G0008 17G0009 17G0010 17G0011 17G0012 17G0013 17G0014 17G0015 17G0016 17G0017 17G0018 17G0019 17G0020 17G0021 17G0022 17G0023 17G0024 17G0025 17G0026 17G0027 17G0028 17G0029 17G0030 17I0001 17I0002 17I0003 17I0004 17I0005 17I0006 17I0007 17I0008 17I0009 17I0010 17I0011 17I0012 17I0013 17I0014 17I0015 17I0016 17I0017 17I0018 17I0019 17I0020 17I0021 17I0022 17I0023 17I0024 17I0025 17I0026 17I0027 17I0028 17I0029 17I0030 17I0031 17I0032 17I0033 17J0002 17J0003 17J0004 17J0005 17J0006 17J0007 17J0008 17J0009 17J0010 17J0011 17J0012 17J0013 17J0014 17J0015 17J0016 17J0017 17J0018 17J0019 17J0020 17J0021 17J0022 17J0023 17J0024 17J0025 17J0026 17J0027 17J0028 17J0029 17J0030 17K0001 17K0002 17K0003 17K0004 17K0005 17K0006 17K0042 17K0043 17K0044 17K0045 17K0046 17K0047 17K0048 17K0049 17K0050 17K0051 17K0052 17K0053 17K0054 17K0055 17K0056 17K0057 17K0058 17K0060 18D0001 18D0002 18D0003 18D0004 18D0005 18D0006 18D0007 18D0008 18D0009 18D0010 18D0011 18D0012 18D0013 18D0014 18D0015 18D0016 18D0017 18D0018 18D0019 18D0020 18D0021 18D0022 18D0023 18D0024 18D0025 18D0026 18D0027 18D0028 18D0029 18D0030 18D0031 18D0032 18D0033 18D0034 18D0035 18D0036 18D0037 18D0038 18D0039 18D0040 18D0041 18D0042 18D0043 18D0044 18D0045 18D0046 18D0047 18D0048 18D0049 18D0050 18D0051 18D0052 18D0053 18D0054 18D0055 18D0056 18D0057 18D0058 18D0059 18D0060 18F0001 18F0002 18F0003 18F0004 18F0005 18F0006 18F0007 18F0008 18F0009 18F0010 18F0011 18F0012 18F0013 18F0014 18F0015 18F0016 18F0017 18F0018 18F0019 18F0020 18F0021 18F0022 18F0023 18F0024 18F0025 18F0026 18F0027 18F0028 18F0029 18F0030 18L0001 18L0002 18L0004 19A0001 19A0002 19A0003 19A0004 19A0005 19A0006 19A0007 19A0008 19A0009 19A0010 19A0011 19A0012 19A0013 19A0014 19A0015 19A0016 19A0017 19A0018 19A0019 19A0020 19A0021 19A0022 19A0023 19A0024 19A0025 19A0026 19A0027 19A0028 19A0029 19A0030 19A0031 19A0032 19A0033 19A0034 19A0035 19A0036 19A0037 19A0038 19A0039 19A0045 19A0046 19A0047 19A0048 19A0049 19A0050 19A0051 19A0052 19A0053 19A0054 19A0055 19A0056 19A0057 19A0058 19A0059 19A0060 19C0001 19C0002 19C0003 19C0004 19C0005 19C0006 19C0007 19C0008 19C0011 19C0012 19C0013 19C0014 19C0015 19C0016 19C0017 19C0018 19C0019 19C0020 19C0021 19C0022 19C0023 19C0024 19C0025 19C0026 19C0027 19C0029 19C0030
Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland is recalling Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medic due to The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026