Bien-Air Surgery Sa: Medical Device Recall in 2020 - (Recall #: Z-0176-2021)

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 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

Product Classification:

Class II

Date Initiated: September 11, 2020

Date Posted: October 28, 2020

Recall Number: Z-0176-2021

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 1600407 / Catalog number 1600407-001 Serial Numbers: 16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated