Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
Reported: October 28, 2020 Initiated: September 11, 2020 #Z-0180-2021
Product Description
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
Reason for Recall
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Details
- Recalling Firm
- Bien-Air Surgery Sa
- Units Affected
- N/A
- Distribution
- US Nationwide distribution including in the states of CA, MI and MN.
- Location
- Le Noirmont, N/A
Frequently Asked Questions
What product was recalled? ▼
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.. Recalled by Bien-Air Surgery Sa. Units affected: N/A.
Why was this product recalled? ▼
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0180-2021.
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