Events

Recall of Device Recall Jet Denture Repair Acrylic

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-1043-04
  • 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=33518
  • 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
    Resin, Denture, Relining, Repairing, Rebasing - Product Code EBI
  • 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 Denture Repair Acrylic
  • Model / Serial
    product code 1220, box lot 1220-4023, bottle lot 60274005/04AB - clear;  product code 1223, box lot 1223-4024, bottle lot 60274005/04AB -clear and box lot 1223-4025, bottle lot 12163001/01AN - meharry
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package
  • 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