FDA-Device2018-04-18Class II

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

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.

Sold states
US Nationwide Distribution
Manufactured in
Ignaz-Glaser-Strasse 53, Burmoos, Austria
Products
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1351-2018

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief