Entellus Medical Shaver System Foot Pedal Recalled for Magnet Defect
Bien-Air Surgery Sa is recalling Entellus Medical Shaver System foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that could cause an unstoppable motor to start unattended during surgical procedures, posing a significant risk of injury.
Plain-English summary
Bien-Air Surgery Sa is recalling the Entellus Medical Shaver System Foot Pedal (REF SSA-102). The recall is due to a defect where the magnet located inside the foot pedal may come off. This failure may result in the unattended start of the motor, which could become unstoppable.
The affected product is designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology. The recall covers units distributed nationwide in the United States, including in the states of California, Michigan, and Minnesota. Specific serial numbers are listed in the official recall documentation.
Healthcare facilities and users should stop using the affected foot pedals immediately. Bien-Air Surgery Sa is the recalling firm responsible for the corrective action.
The recalled product
- Product
- 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.
- Manufacturer
- Bien-Air Surgery Sa
Distribution
Part of a larger recall action
This product is one of 5 recalled by Bien-Air Surgery Sa under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Bien-Air Surgery Sa
See all →- SevereStryker S2 Mini Foot Pedal Recalled Due to Magnet Defect
FDA (Devices) · 2020-10-28
- SevereBien-Air Surgery Foot Pedal Recalled Due to Magnet Detachment Risk
FDA (Devices) · 2020-10-28
- HighBien-Air Surgery OSSEOSTAP Footcontrol Recalled for Magnet Defect
FDA (Devices) · 2020-10-28
- SevereBien-Air Surgery Multifunction Pedal Recalled Due to Magnet Failure Risk
FDA (Devices) · 2020-10-28
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