# FDA recall Z-1351-2018

> **W & H DentalWerk Burmoos GMBH - Site 1** · Class II · device recall initiated 2017-12-21.

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1351-2018
- **Recalling firm:** W & H DentalWerk Burmoos GMBH - Site 1
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-21
- **Report date:** 2018-04-18
- **Termination date:** 2019-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burmoos, Austria

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1351-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1351-2018. Source: US FDA. Licensed CC0.

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