Reported Apr 18, 2018 · Terminated
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical…
W & H DentalWerk Burmoos GmbH - Site 1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: W & H DentalWerk Burmoos GMBH - Site 1 · Ignaz-Glaser-Strasse 53 · Burmoos · N/A
Is this the product you have?
- Foot Controls ModelS-N1
- and S-N2 Product UsageVariable foot control for use with drive units operating mechanical instruments
- Lot codes and dates
- REFSerial number "SN" from to (including)
0504620005046200050462110504621006202400062024003028500030285001
2240023429E02201E02485E01011E01033E01035E010712431534040E01358E016580100102318
- REF
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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