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