Bien-Air Surgery Sa: Medical Device Recall in 2020 - (Recall #: Z-0178-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 11, 2020

Date Posted: October 28, 2020

Recall Number: Z-0178-2021

Event ID: 86419

Reason for Recall:

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

Status: Ongoing

Product Quantity: Total US = 1120 foot pedals

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

Distribution Pattern:

US Nationwide distribution including in the states of CA, MI and MN.

Voluntary or Mandated:

Voluntary: Firm initiated