Bien-Air Surgery Multifunction Pedal Recalled Due to Magnet Failure Risk
Bien-Air Surgery is recalling 1,120 OsseoDuo multifunction 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 involves a medical device with a defect that can cause an unstoppable motor to start unattended, posing a significant risk of serious injury to patients or operators during surgical procedures.
Plain-English summary
Bien-Air Surgery Sa is recalling 1,120 units of the OsseoDuo Multifunction Pedal (Model 1600517, Catalog number 1600517-001). These devices are intended to convert electrical energy to mechanically drive attachments, microsaws, shaver blades, burs, and perforator tools for cutting and shaping bone, including the spine and cranium.
The recall is being issued because the magnet located inside the foot pedal may come off. This failure may result in an unattended start of the motor, which could become unstoppable. The affected units were distributed nationwide in the United States, including in the states of California, Michigan, and Minnesota.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the recall notice. If a device is found, it should be removed from service immediately to prevent potential injury from the uncontrolled motor operation.
The recalled product
- Product
- Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including…
- 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
FDA (Devices) · 2020-10-28
- 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
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