Stryker S2 Mini Foot Pedal Recalled Due to Magnet Defect
Bien-Air Surgery is recalling Stryker S2 Mini 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. The hazard involves an unstoppable motor during surgical procedures, which poses a significant risk of injury to patients or operators, meeting the criteria for a Severe rating.
Plain-English summary
Bien-Air Surgery Sa is recalling the Stryker Instruments S2 Mini Foot Pedal (REF 5452-007-000) in the United States. The recall involves 1,120 foot pedals distributed nationwide, including in California, Michigan, and Minnesota. The S2 Mini Drill System is designed for light drilling of bones during surgical operations such as stapedotomy or ossiculoplasty.
The recall was initiated because the magnet located inside the foot pedal may come off. This defect may result in an unattended start of the motor, which may become unstoppable. 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 are identified by Model 1600983 / Catalog number 1600983-001 and specific serial numbers listed in the official recall notice. Users should contact the recalling firm for instructions on how to return or replace the devices.
The recalled product
- Product
- Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot ped
- 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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