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W & H DentalWerk Burmoos GMBH - Site 1 recalls Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanic
Recalled April 18, 2018 · FDA recall Z-1351-2018 · W & H DentalWerk Burmoos GMBH - Site 1
Hazard
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. · FDA Class II
Sold at
US Nationwide Distribution
Description
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.
Product
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Manufacturer(s)
W & H DentalWerk Burmoos GMBH - Site 1
Made in
Austria
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →