Recall Z-0180-2021— Bien-Air Surgery Sa

Name: FDA recall Z-0180-2021
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: K083720. 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.. 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

K083720 — OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80KBien-Air Surgery SA·cleared 2009-03-20

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

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.

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.