Bien-Air Surgery Footctrl Osseodoc devices with serial numbers 16C0017, 16F0013, 16I0009, 16K0017, 17F0039, 17I0015, 17L0013 may have a magnet that can detach and cause the device to start unexpectedly.
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Bien-Air Surgery Footctrl Osseodoc devices with specific serial numbers were recalled because a magnet inside the foot pedal could detach and cause the device to start unexpectedly without warning. This poses a risk of uncontrolled movement during surgery.
The magnet inside the foot pedal can become detached and cause the device to start unexpectedly. This could lead to uncontrolled movement of surgical tools during procedures, potentially causing injury to patients or staff.
Surgical professionals using the Bien-Air Surgery Footctrl Osseodoc device with the listed serial numbers are most at risk. Patients and staff in operating rooms where this device is used could also be affected.
Check the serial numbers on your device: 16C0017, 16F0013, 16I0009, 16K0017, 17F0039, 17I0015, or 17L0013. The device is a surgical foot pedal used for bone cutting and shaping.
Look for the serial numbers 16C0017, 16F0013, 16I0009, 16K0017, 17F0039, 17I0015, or 17L0013 on your device.
The magnet inside the foot pedal may detach and cause the device to start unexpectedly, which could lead to uncontrolled movement during surgery.
The affected serial numbers are 16C0017, 16F0013, 16I0009, 16K0017, 17F0039, 17I0015, and 17L0013.
The recall does not require immediate stoppage; however, you should check the serial number and follow the action steps if affected.
We’ve drafted a message you can send Bien-Air Surgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0176-2021 — Bien-Air Surgery Bien-Air Surgery Hello, I own a Bien-Air Surgery that is covered by recall Z-0176-2021 from Bien-Air Surgery. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
