Events

Recall of Device Recall Jet Tooth Shade Powder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lang Dental Mfg Co, 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
    29304
  • Event Risk Class
    Class 3
  • Event Number
    Z-1041-04
  • Event Initiated Date
    2004-06-07
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33515
  • 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
    Crown And Bridge, Temporary, Resin - Product Code EBG
  • Reason
    The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
  • Action
    Lang Dental sent recall letters dated 6/7/04 to their direct accounts, informing them of the contamination of the acrylic resin powders with the black particles and requesting the return of any existing inventory of the affected lots of product for replacement. Distributors were requested to sub-recall the products from their accounts. Follow-up letters were sent to the accounts on 6/14/04, clarifying the lot numbers affected to include both the lot number on the box and the lot number on the bottom of the squeeze bottles affected.

Device

Device Recall Jet Tooth Shade Powder
  • Model / Serial
    2 oz. bottles:  box ot 1410-4117, bottle lot 60074003/04AD - shade 62;  box lot 1410-4120, bottle lot 60044001/01AE - shade 59;  box lot 1410-4122, bottle lot 60123005/03AF - shade 69; 4 oz. bottles:  box lot 1420-4118, bottle lot 60083006/04AK - shade 65;  box lot 1420-4119, bottle lot 60024001/01AJ - shade LI;  box lot 1420-4120, bottle lot 60133003/03AJ - shade 77;  box lot 1420-4123, bottle lot 60143005/03AK - shade 81;  box lot 1420-4126, bottle lot 60103002/02AD - shade 67;  box lot 1420-4128, bottle lot 60024001/01AL - shade LI;  box lot 1420-4130, bottle lot 60063002/02AU - shade 61;  box lot 1420-4131, bottle lot 60074003/04AE - shade 62;  box lot 1420-4134, bottle lot 60173001/01BU - shade C4;  box lot 1420-4135, bottle lot 60084001/01AC - shade 65
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2 oz.) plastic squeeze bottles and product code 1420, Net Wt. 100 g (4 oz.) plastic squeeze bottles; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969
  • Manufacturer
    Lang Dental Mfg Co, Inc.

Manufacturer

Lang Dental Mfg Co, Inc.
  • Manufacturer Address
    Lang Dental Mfg Co, Inc., 175 Messner Dr, Wheeling IL 60090-6433
  • Source
    USFDA