Bien-Air Surgery OSSEOSTAP Footcontrol Recalled for Magnet Defect
Bien-Air Surgery is recalling OSSEOSTAP 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Bien-Air Surgery Sa is recalling the OSSEOSTAP Footcontrol (REF 1600686-001), an active medical device used during Ear, Nose and Throat (ENT) surgery. The device converts electrical energy into mechanical rotation. The recall involves 1,120 foot pedals distributed nationwide in the United States, including in California, Michigan, and Minnesota.
The recall was initiated because the magnet located inside the foot pedal may come off. This defect may result in the unattended start of an unstoppable motor. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users should stop using the affected foot pedals immediately. Affected units can be identified by the model number 1600686, catalog number 1600686-001, and specific serial numbers listed in the official recall notice. Users should contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
- 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
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- SevereBien-Air Surgery Foot Pedal Recalled Due to Magnet Detachment Risk
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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