FDADecember 21, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

w h dentalwerk burmoos gmbh site 1

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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