Recall Z-1351-2018— W & H DentalWerk Burmoos GMBH - Site 1
Class II · Terminated
Class II FDA medical device recall by W & H DentalWerk Burmoos GMBH - Site 1, initiated 2017-12-21, terminated 2019-06-07. It names one FDA 510(k) clearance: K060287. Product: Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.. Reason: 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..
- Recalling firm
- W & H DentalWerk Burmoos GMBH - Site 1
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-21
- Terminated
- 2019-06-07
- Firm location
- Burmoos, Austria
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.