Bien-Air Surgery Foot Pedal Recalled Due to Magnet Detachment Risk
Bien-Air Surgery is recalling 1,120 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 mechanical defect that can cause an unstoppable motor to start unattended, posing a significant risk of injury to patients or operators.
Plain-English summary
Bien-Air Surgery Sa is recalling 1,120 units of the Bien-Air Surgery REF 1600407-001 Foot Pedal (OSSEODOC). This device is intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is being issued because the magnet located inside the foot pedal may come off. If this occurs, it may result in an unattended start of an unstoppable motor. The affected units were distributed nationwide in the United States, including in the states of California, Michigan, and Minnesota.
Affected units are identified by Model 1600407 and Catalog number 1600407-001. The specific serial numbers included in this recall are 16C0017, 16F0013, 16I0009, 16K0017, 17F0039, 17I0015, and 17L0013. Users should stop using the affected foot pedals and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
- 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 →- SevereEntellus Medical Shaver System Foot Pedal Recalled for Magnet Defect
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- HighBien-Air Surgery OSSEOSTAP Footcontrol Recalled for Magnet Defect
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- SevereBien-Air Surgery Multifunction Pedal Recalled Due to Magnet Failure Risk
FDA (Devices) · 2020-10-28
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