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 mechanical i…

Recall date

December 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1351-2018

FDA classification

Class II

Brand / firm

W & H DentalWerk Burmoos GMBH - Site 1

Sold / distributed

US Nationwide Distribution

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.