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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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- SevereBien-Air Surgery Multifunction Pedal Recalled Due to Magnet Failure Risk
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