Bien-Air Surgery SA

Code	Device name	Class	Specialty	Clearances	Most recent
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Class II	Ear, Nose, Throat	1	2022-11-02
HBC	—	—	—	1	2022-10-31

Date	Severity	Status	Recall #	Product	Code	Reason
2020-09-11	Class II	Ongoing	Z-0180-2021	Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has…	—	The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11	Class II	Ongoing	Z-0179-2021	Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has bee…	—	The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11	Class II	Ongoing	Z-0178-2021	Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert…	—	The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11	Class II	Ongoing	Z-0177-2021	Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to con…	—	The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11	Class II	Ongoing	Z-0176-2021	Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mec…	—	The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

Date	K-number	Device	Code	Class	Specialty
2022-11-02	K221184	ORiGO System	ERL	Class II	Ear, Nose, Throat
2022-10-31	K213697	ORiGO System	HBC	—	—

Clearance cadence by quarter