Field Safety Notice! Foot control S-N1/S-N2

Dear Madam/ dear Sir

We hereby inform you that within the framework of our continuous product observation of the market, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2.

Affected foot controls:

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 seperately.

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 the functions automatic thread cutting and automatic screwing in of implants for the time being. These operations have to be conducted manually.

So far, no incident has been reported. The health and safety of patients are our highest priority. Thus, we consider it our task to inform all users who use the potentially affected products.

We kindly ask you to fill out the attached reply form!

After your feedback has been checked, we will inform you whether the reported foot control is affected or can be used without any problems. In case the foot control is affected, you will be contacted by the W&H organization and informed about further actions.

We deeply regret the inconvenience and thank you for your understanding.