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:

"REF" Foot control Serial number "SN"
  from to (including)
05046200 22400 23429
05046200 E02201 E02485
05046211 E01011 E01033
05046210 E01035 E01071
06202400 24315 34040
06202400 E01358 E01658
30285000 01001 02318
30285001 01001 02318

 

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.

REF, SN
REF, SN display
REF, SN
REF, SN display

In order to be of quick service for you, please fill in the data completely. Should you have more devices, we kindly ask you to fill out this form for each foot control separately:
 

Please see REF and Serial number "SN" on the images above.

Please fill in the REF-Number

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