Recall Z-1351-2018
W & H DentalWerk Burmoos GMBH - Site 1 · initiated December 21, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Codes / lots: REF: 05046200 05046200 05046211 05046210 06202400 06202400 30285000 30285001 Serial number "SN" from to (including) 22400 23429 E02201 E02485 E01011 E01033 E01035 E01071 24315 34040 E01358 E01658 01001 02318
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.
FDA-determined cause: Process change control
Action taken
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
Details
- Recall number
- Z-1351-2018
- Initiated
- December 21, 2017
- Terminated
- June 7, 2019
- Product code
- EBW – Controller, Foot, Handpiece And Cord
- Distribution
- US Nationwide Distribution
- Recalling firm
- W & H DentalWerk Burmoos GMBH - Site 1, Burmoos