Bien-Air Surgery recall
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into…
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 1600686 / Catalog number 1600686-001 Serial Numbers: 18D0006 18D0007 18D0008 18D0009 18D0010 18D0013 18D0014 18D0015 18D0016 18D0017 18D0018 18D0019 18D0020 18D0021 18D0022 18D0023 18D0024 18D0025 18D0026 18D0027 18D0028 18D0029 18D0030 16A0005 16A0009 16A0010 16A0011 16A0014 17D0011 17G0006
- Product
- Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into…
- 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)