Medical Device Alert - Field Safety Notice Foot control S-N1/S-N2

News From: www.gov.uk

W&H Dentalwerk have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2.

So far, no incident has been reported. 

The affected foot controls were delivered either with surgical units (W&H Implantmed and W&H Elcomed produced between March 2016 and September 2017) or separately.

To access the effected serial numbers click here

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 can, in the worst case, lead to a serious injury of the patient.

Due to this potential malfunction, the affected products (foot control) must not be used for thread cutting and screwing in of implants for the time being. These operations have to be conducted manually.

Click here to access the alert

Tags: 
Alert
W&H
Foot Control
MHRA