Recall Z-0178-2021— Bien-Air Surgery Sa

Name: FDA recall Z-0178-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-11

Class II · Ongoing

Class II FDA medical device recall by Bien-Air Surgery Sa, initiated 2020-09-11. It names one FDA 510(k) clearance: K143492. Product: 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: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor..

Recalling firm: Bien-Air Surgery Sa
Classification: Class II
Status: Ongoing
Initiated: 2020-09-11
Firm location: Le Noirmont, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K143492 — OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpieceBien-Air Surgery SA·cleared 2015-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.