Events

Recall of Device Recall Lightspeed LSX Files

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ormco/Sybronendo.

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
    64163
  • Event Risk Class
    Class 2
  • Event Number
    Z-0765-2013
  • Event Initiated Date
    2012-12-12
  • Event Date Posted
    2013-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115470
  • 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
    File pulp canal endodontic - Product Code EKS
  • Reason
    The length markings on the lightspeed lsx files were wrong.
  • Action
    Sybron Endo sent a Urgent: Medical Device Recall letter dated December 21, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has come to our attention that the length rings laser-etched on several lots of the Lightspeed LSX Files are inaccurate. We are asking for the product to be returned since use of the file could be a safety risk due to misadjustment of the file length. Please contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement.

Device

Device Recall Lightspeed LSX Files
  • Model / Serial
    Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the country of Canada.
  • Product Description
    Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. || An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal.
  • Manufacturer
    Ormco/Sybronendo

Manufacturer

Ormco/Sybronendo
  • Manufacturer Address
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA