Device Recall Foot Control 의 리콜

Recall

79533

Class 2

Z-1351-2018

2017-12-21

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162600

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.

On December 22, 2017 a field safety notice was issued to customers notifying them of the potential problem with the foot controls. On February 15, 2018 a replacement foot control was sent to customers with instructions to unplug the original foot control, cut the cable once disconnected to an electrical source and properly dispose of. The replacement foot control is to be used instead. Questions or concerns can be directed to footcontrol@wh.com