Events

Recall of Device Recall Solara Replacement Turbine

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    36920
  • Event Risk Class
    Class 2
  • Event Number
    Z-0313-2007
  • Event Initiated Date
    2006-12-01
  • Event Date Posted
    2006-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49568
  • 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
    dental handpiece accessory - Product Code EFA
  • Reason
    End cap component can disassemble.
  • Action
    The recalling firm sent recall letters to dealers and doctors via certified mail, return receipt on 12/6/06. Letters to the foreign accounts were sent via UPS or other traceable methods.

Device

Device Recall Solara Replacement Turbine
  • Model / Serial
    Part number 064900, Lot numbers 1694789, 1697998, 1699566, and 1703516.0
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Canada and Japan.
  • Product Description
    Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.
  • Manufacturer
    Stardental Division

Manufacturer

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