FDA Medical Device Recalls (openFDA)
W & H DentalWerk Burmoos GMBH - Site 1: Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
- Recall number
- Z-1351-2018
- Recalling firm
- W & H DentalWerk Burmoos GMBH - Site 1
- Product
- Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
- Status
- Terminated
- Initiated
- 2017-12-21
- Posted
- not on file
- Terminated
- 2019-06-07
- Reason
- 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.
- 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 footcontrol@wh.com
- Quantity
- not on file
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K060287"]
- PMA numbers
- not on file
- Product code
- EBW
- Firm FEI
- 3003755849
- Firm city
- Burmoos
- Firm state
- not on file
- Firm country
- Austria
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28