Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot Recalled by W & H DentalWerk Burmoos GMBH - Site 1 Due to During continuous postmarket surveillance activities, we have noticed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact W & H DentalWerk Burmoos GMBH - Site 1 directly.
Affected Products
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Why Was This Recalled?
During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control might not switch back to zero position when the pedal is released. Consequently, the motor keeps rotating. If this happens during automatic thread cutting or automatic screwing-in of implants, it may, in the worst case, lead to a serious injury of the patient.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About W & H DentalWerk Burmoos GMBH - Site 1
W & H DentalWerk Burmoos GMBH - Site 1 has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report