Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot… — Class II medical device recall Z-1351-2018
Terminated recall by W & H DentalWerk Burmoos GMBH - Site 1, reported 2018-04-18, distributed nationwide. During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual fo
| Recall number | Z-1351-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | W & H DentalWerk Burmoos GMBH - Site 1, Burmoos, Austria |
| Recall initiated | 2017-12-21 |
| Classified | 2018-04-10 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2019-06-07 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Model numbers | 05046200, 05046210, 05046211, 06202400, 30285000, 30285001, S-N1, S-N2 |
Product
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.