Events

Recall of Device Recall StarDental Classique(TM) Diamond Dental Bur

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

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
    65283
  • Event Risk Class
    Class 2
  • Event Number
    Z-1522-2013
  • Event Initiated Date
    2013-05-28
  • Event Date Posted
    2013-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118456
  • 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
    Bur, diamond coated, reprocessed - Product Code NME
  • Reason
    Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.
  • Action
    Dental EZ Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter on May 28, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 866-383-4636 ext.4350 for questions regarding this recall.

Device

Device Recall StarDental Classique(TM) Diamond Dental Bur
  • Model / Serial
    Item 200169, lot numbers 2140459 and 2177284; Item 200174, lot numbers 2151776 and 2158861; Item 200276, lot number 2149190; Item 200288, lot number 2143968; Item 200329, lot number 2139572; Item 200339, lot number 2159105; Item 200354, lot number 2149191; Item 200394, lot number 2164110; Item 200402, lot numbers 2143162 and 2156621; Item 200415, lot number 2139573; Item 200418, lot numbers 2153439, 2163438, 2166502, 2171448, 2173003, and 2175575; Item 200433, lot numbers 2153440 and 2171670; Item 200448, lot numbers 2139574, 2157306, and 2167344; Item 200468, lot number 2151894; Item 200473, lot numbers 2146257, 2156268, and 2166207; Item 200483, lot numbers 2141173, 2151723, and 2161240; Item 200496, lot numbers 2144739, 2151899, 2157307 and 2166208.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan.
  • Product Description
    StarDental Classique(TM) Diamond Dental Bur. || Used for specific applications in dental procedures.
  • Manufacturer
    Dental EZ Stardental Division

Manufacturer

Dental EZ Stardental Division
  • Manufacturer Address
    Dental EZ Stardental Division, 1816 Colonial Village Ln, Lancaster PA 17601-5891
  • Source
    USFDA