Recall of Entellus Medical SSA-102 shaver foot pedals with serial numbers starting 16H0001 to 19C0030. Magnet may detach causing unattended motor start during surgery.
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Entellus Medical's SSA-102 shaver system foot pedals with specific serial numbers are being recalled because a magnet inside may detach and cause the shaver to start unexpectedly during surgery. This poses a risk of uncontrolled movement that could harm patients.
The magnet inside the foot pedal can become loose and detach during use. If it does, the shaver may start automatically without supervision, potentially causing unintended movement of surgical instruments and harming patients.
Surgical staff and hospitals using the Entellus Medical SSA-102 shaver system with serial numbers listed in the recall. Patients undergoing surgery with this device are at risk if the magnet detaches.
Check if your shaver system has the Entellus Medical SSA-102 model with serial numbers starting from 16H0001 through 19C0030 as listed in the recall notice.
Immediately stop using the shaver system if you have the recalled serial numbers listed in the recall notice.
The Entellus Medical SSA-102 shaver system foot pedal with serial numbers starting from 16H0001 through 19C0030.
Check the serial number on your shaver system; if it starts with 16H0001 through 19C0030, it is affected.
Stop using it immediately and contact Entellus Medical for further instructions.
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-0180-2021 — Bien-Air Surgery Bien-Air Surgery Hello, I own a Bien-Air Surgery that is covered by recall Z-0180-2021 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.
