Reported Oct 28, 2020 · Ongoing

Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended 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 1600517-001 SN ******* MULTIFUNCTION
  • PEDAL OSSEODUO - Product UsageProduct
  • Usageintended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium
Lot codes and dates
  • Model 1600517 / Catalog
  • number 1600517-001 Serial Numbers

    144 of 144 codes

    • 18F0017
    • 18F0030
    • 18G0003
    • 18G0018
    • 18G0019
    • 18G0020
    • 18G0021
    • 18G0025
    • 18H0016
    • 18H0017
    • 18H0018
    • 18H0019
    • 18H0026
    • 18H0027
    • 18I0003
    • 18I0004
    • 18I0005
    • 18I0006
    • 18I0018
    • 18I0022
    • 18I0023
    • 18I0024
    • 18I0025
    • 18I0026
    • 18I0027
    • 18I0028
    • 18I0029
    • 18I0030
    • 18J0001
    • 18J0002
    • 18J0003
    • 18J0004
    • 18J0005
    • 18J0009
    • 18J0010
    • 18J0011
    • 18J0012
    • 18J0013
    • 18J0014
    • 18J0015
    • 18J0016
    • 18J0017
    • 18J0018
    • 18J0019
    • 18J0020
    • 18J0021
    • 18J0022
    • 18J0023
    • 18J0024
    • 18J0025
    • 18J0026
    • 18J0037
    • 18J0038
    • 18J0039
    • 18J0040
    • 18J0041
    • 18L0012
    • 18L0014
    • 18L0017
    • 18L0018
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Bien-Air Surgery Sa recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 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.