Bien-Air Surgery
Medical device recall Z-0177-2021. Published in FDA’s Enforcement Report on Oct 28, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 28, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- Total US = 1120 foot pedals how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended 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.
Total US = 1120 foot pedals, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 1600517 / Catalog number 1600517-001 Serial Numbers: 18F0017 18F0030 18G0003 18G0018 18G0019 18G0020 18G0021 18G0025 18H0016 18H0017 18H0018 18H0019 18H0026 18H0027 18I0003 18I0004 18I0005 18I0006 18I0018 18I0022 18I0023 18I0024…
Every code shown here, 1,210 characters
Model 1600517 / Catalog number 1600517-001 Serial Numbers: 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 18L0019 18L0020 18L0021 18L0023 19B0021 19B0022 19B0023 19B0024 19B0025 19B0028 19B0029 19B0030 19B0038 19B0041 19B0042 19B0043 19B0044 19B0051 19B0052 19B0053 19B0054 19B0055 19B0056 19B0058 19B0059 19E0004 19E0005 19E0008 19E0009 19E0011 19E0012 19E0013 19E0014 19E0015 19E0016 19E0017 19E0028 19E0029 19E0030 19E0035 19E0037 19E0047 19E0048 19E0053 19E0054 19E0055 19E0056 19E0057 19E0058 19E0060 19E0063 19E0064 19E0068 19E0069 16A0015 16A0016 16G0024 16I0007 16I0026 16I0027 16I0028 16I0029 16K0027 17A0009 17B0008 17B0009 17B0010 17B0011 17B0012 17B0013 17B0039 17B0040 17B0041 17B0049 17B0050 17C0012 17C0013 17E0033 17G0004 17G0024 17G0025 19E0006 19E0007 19E0010
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution including in the states of CA, MI and MN.
The states and territories these words name
- California
- Michigan
- Minnesota
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 11, 2020.
- FDA classified it on Oct 21, 2020.
- FDA’s Enforcement Report published it on Oct 28, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bien-Air Surgery Sa, of Le Noirmont, Switzerland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.