Events

Recall of Titan 3 5K LowSpeed Motor

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
    56489
  • Event Risk Class
    Class 3
  • Event Number
    Z-2354-2010
  • Event Initiated Date
    2010-08-11
  • Event Date Posted
    2010-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93772
  • 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
    Handpiece, belt and/or gear driven, dental - Product Code EFA
  • Reason
    The housing of 5k motor is labeled as a 20k motor.
  • Action
    DentalEZ group/Star Dental Division sent a "Medical Device Recall" letter to consignees on 8/11/10, informing them that the device's 5K motor was mislabeled as a 20K motor. Customers are to stop using of the device, and return to the manufacturer or to the distributor using supplied shipping labels. Replacement devices will be sent to customers at no charge. Consignees are to complete and return a form indicating whether they have any affected devices, and whether customers have been contacted about this recall. Customers can contact DentalEZ at 866-383-4636 .

Device

Titan 3 5K LowSpeed Motor
  • Model / Serial
    Part number 262261, Lot number 1925391
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: States of IN and TX
  • Product Description
    Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
  • 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