Reported Oct 28, 2020 · Ongoing

Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to…

Bien-Air Surgery Sa

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bien-Air Surgery Sa · rue de l' ouest 2b · Le Noirmont, N/A · N/A

Is this the product you have?

  • Bien-Air Surgery REF 1600407-001 SN ****
  • FOOTCTRL OSSEODOC - Product Usageintended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones
Lot codes and dates
  • Model 1600407 / Catalog
  • number 1600407-001 Serial Numbers16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013
Amount recalled
Total US = 1120 foot pedals

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.