Recall of Bien-Air Surgery OSSEODUO multifunction pedal models with serial numbers starting 18F0017-19E0069. Magnet may detach and cause unattended motor start without user control.
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Bien-Air Surgery's OSSEODUO multifunction pedal devices are being recalled because a magnet inside the foot pedal can detach and cause the motor to start uncontrollably without user input. This poses a risk of unintended movement during surgery.
The magnet inside the foot pedal can become dislodged during use, causing the motor to start automatically without the user's control. This could lead to unintended movement of surgical instruments during procedures, potentially causing injury.
Surgical professionals using the OSSEODUO multifunction pedal devices with specific serial numbers listed in the recall. Patients undergoing surgery with these devices are at risk of unintended movement.
Check the serial number on the device, which starts with 18F0017 through 19E0069. The product is a multifunction pedal used in surgical procedures for bone cutting and shaping.
Look for the serial number on the device, which begins with 18F0017 through 19E0069.
If the magnet detaches, the motor may start uncontrollably; stop using the device immediately.
The OSSEODUO multifunction pedal with serial numbers starting 18F0017 through 19E0069.
Check the serial number on the device; affected units have serial numbers listed in the recall (18F0017 to 19E0069).
Immediately stop using the device as it may start uncontrollably without user input.
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-0177-2021 — Bien-Air Surgery Bien-Air Surgery Hello, I own a Bien-Air Surgery that is covered by recall Z-0177-2021 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.
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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.
