Events

Recall of Device Recall Milestone Scientific Wand STA Handpiece

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Milestone Scientific, Inc..

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
    70742
  • Event Risk Class
    Class 3
  • Event Number
    Z-1952-2015
  • Event Initiated Date
    2015-02-11
  • Event Date Posted
    2015-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137361
  • 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
    Syringe, cartridge - Product Code EJI
  • Reason
    Wand handpiece was mislabeled as sta handpiece. the wand handpiece cannot be installed in the sta instrument.
  • Action
    Milestone Scientific notified their customers via e-mail and phone on 2/11/2015.

Device

Device Recall Milestone Scientific Wand STA Handpiece
  • Model / Serial
    Lot 140103
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US in FL, IL, NY WA and Puerto Rico, Israel, Croatia, Italy, Australia, Germany, Colombia, UK, Sweden, and UAE.
  • Product Description
    Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.
  • Manufacturer
    Milestone Scientific, Inc.

Manufacturer

Milestone Scientific, Inc.
  • Manufacturer Address
    Milestone Scientific, Inc., 220 S Orange Ave, Livingston NJ 07039-5804
  • Manufacturer Parent Company (2017)
    Milestone Scientific, Inc.
  • Source
    USFDA