Z-1351-2018Class II

Foot Controls Model: S-N1 and S-N2

Name: Z-1351-2018 Foot Controls Model: S-N1 and S-N2
Creator: W & H DentalWerk Burmoos GMBH - Site 1
Published: 2017-12-21
License: https://open.fda.gov/license/

W & H DentalWerk Buermoos GmbH / initiated 2017-12-21 / Terminated

FDA source

W & H DentalWerk Burmoos GMBH - Site 1 began a recall of Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments on 2017-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1351-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-21
Posted: 2018-04-11
Terminated: 2019-06-07
Recalling firm: W & H DentalWerk Buermoos GmbH
Product: Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Product code: EBW Controller, Foot, Handpiece And Cord
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 root cause: Process change control
Action: 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 [email protected]
Distribution: US Nationwide Distribution
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1351-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1351-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10

Product code EBW

K060287Class IDrilltech, Ism, Implantunit, Zimmer Surgical Motor SystemW&H Dentalwerk Buermoos GmbH / cleared 2006-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)