Events

Recall of Device Recall Foot Control

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by W & H DentalWerk Burmoos GMBH - Site 1.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79533
  • Event Risk Class
    Class 2
  • Event Number
    Z-1351-2018
  • Event Initiated Date
    2017-12-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162600
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Controller, foot, handpiece and cord - Product Code EBW
  • 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.
  • 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

Device

Device Recall Foot Control
  • Model / Serial
    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
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Foot Controls || Model: S-N1 and S-N2 || Product Usage: || Variable foot control for use with drive units operating mechanical instruments.
  • Manufacturer
    W & H DentalWerk Burmoos GMBH - Site 1

Manufacturer

W & H DentalWerk Burmoos GMBH - Site 1
  • Manufacturer Address
    W & H DentalWerk Burmoos GMBH - Site 1, Ignaz-Glaser-Strasse 53, Burmoos Austria
  • Manufacturer Parent Company (2017)
    Pm Privatstiftung
  • Source
    USFDA