April 18, 2018Medical DevicesFDA
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
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.