Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Recalled by Bien-Air Surgery Sa Due to The magnet located inside the foot pedal may...

Date: September 11, 2020
Company: Bien-Air Surgery Sa
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bien-Air Surgery Sa directly.

Affected Products

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.

Quantity: Total US = 1120 foot pedals

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bien-Air Surgery Sa

Bien-Air Surgery Sa has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report