Recall of Device Recall Neos Vanadium Excavator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sybron Dental Specialties.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Excavator, Dental, Operative - Product Code EKC
  • Reason
    The tips of the neos vanadium excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
  • Action
    Sybron Dental wrote to the distributor by letter dated November 20, 2008 and posted Nov 24, 2008 titled "URGENT MEDICAL DEVICE RECALL," informing them of the recall, and the reason for recall. Sybron informed the distributor to return affected batches of product. Any product in stock with the mentioned batch number was replaced at no charge or credited to their account. The consignee was also asked to contact KerrHawe Customer Care at +41 91 610 05 05 to receive an RGA number. The affected product should be returned to KerrHawe at the following address: KerrHawe SA Via Strecce 4 CH-6934 Bioggio Switzerland PLEASE LABEL RETURNED PRODUCT "RECALLED PRODUCT RETURN". In addition, they asked for the completed RETURN FORM to be returned by fax to +41 91 610 05 14


  • Model / Serial
    Batch Numbers: 3105358
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
  • Product Description
    Neos Vanadium Excavator Part Number 591/5 SCHE
  • Manufacturer


  • Manufacturer Address
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
  • Source