W & H DentalWerk recalls foot controls S-N1 and S-N2 models due to potential malfunction causing motor to keep rotating during procedures, risking serious patient injury. Affected units have specific serial numbers and were sold in certain regions.
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.
W & H DentalWerk is recalling foot controls S-N1 and S-N2 models that may malfunction during use, causing the motor to keep rotating and potentially leading to serious patient injury. Affected units have specific serial numbers and were sold with certain drive units.
The foot controls may not return to zero position when released, causing the motor to keep rotating. During automatic thread cutting or screwing-in of dental implants, this could lead to serious patient injury if the motor continues operating.
Dental professionals using the S-N1 and S-N2 foot controls with mechanical instruments are most at risk. Patients undergoing procedures with these devices could face serious injury if the motor continues rotating.
Check for serial numbers starting with 'SN' from 22400 to 23429, E02201 to E02485, E01011 to E01033, E01035, E01071, 24315 to 34040, or E01358 to E01658. These units were sold with specific drive units operating mechanical instruments.
Verify if your foot control has a serial number in the ranges listed in the recall notice.
The foot controls may not return to zero position when released, causing the motor to keep rotating during procedures like automatic thread cutting or screwing-in of dental implants, which could lead to serious patient injury.
Check for serial numbers starting with 'SN' from 22400 to 23429, E02201 to E02485, E01011 to E01033, E01035, E01071, 24315 to 34040, or E01358 to E01658.
The recall notice does not specify a remedy, so contact the manufacturer directly for guidance.
We’ve drafted a message you can send W & H DentalWerk to request your refund or repair — edit it as you like.
Subject: Recall Z-1351-2018 — W & H DentalWerk W & H DentalWerk Hello, I own a W & H DentalWerk that is covered by recall Z-1351-2018 from W & H DentalWerk. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
