Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medi...
FDA Device Recall #Z-0178-2021 — Class II — September 11, 2020
Recall Summary
| Recall Number | Z-0178-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 11, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bien-Air Surgery Sa |
| Location | Le Noirmont, N/A |
| Product Type | Devices |
| Quantity | Total US = 1120 foot pedals |
Product Description
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.
Reason for Recall
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Distribution Pattern
US Nationwide distribution including in the states of CA, MI and MN.
Lot / Code Information
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
Other Recalls from Bien-Air Surgery Sa
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0177-2021 | Class II | Bien-Air Surgery REF 1600517-001 SN ******* MUL... | Sep 11, 2020 |
| Z-0176-2021 | Class II | Bien-Air Surgery REF 1600407-001 SN **** FOOTCT... | Sep 11, 2020 |
| Z-0180-2021 | Class II | Entellus Medical REF SSA-102 SN ******* Shaver ... | Sep 11, 2020 |
| Z-0179-2021 | Class II | Stryker Instruments REF 5452-007-000 SN *******... | Sep 11, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.