Bien-Air Surgery recall
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and…
Why was Bien-Air Surgery recalled?
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 1600407 / Catalog number 1600407-001 Serial Numbers: 16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013
- Product
- Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and…
- Recalling firm
- Bien-Air Surgery Sa
- Quantity
- Total US = 1120 foot pedals
- Distribution
- US Nationwide distribution including in the states of CA, MI and MN.
- Recall date
- October 28, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)