Events

Recall of Device Recall OrthoJet 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-1042-04
  • 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=33516
  • 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 OrthoJet Powder
  • Model / Serial
    a.1) product code 1320, box lot 1320-4005, bottle lot 60274005/04AB;  a.2) product code 040-016, lot 53-1334-4016, empty bottle and cap only;  b.1) product code 1520, box lot 1520-4020, bottle lot 15144002/01AB - Blue; box lot 1520-4023, bottle lot 15244006/01AH - White;  b.2) product code 045-088, box lot 53-1593-4006, bottle lots 15224001/01AQ - red, 15203002/01BS - orange, 15144002/01AA - blue and 15124003/01AP - black, and box lot 53-1593-4007, bottle lots 15124003/01AQ - black, 15144002/01AC - blue, 15203002/01BU - orange, 15224001/01AT - red, 15244006/01AF - white, 15263001/01CD - yellow;  c.1) product code 2720, box lot lot 2720-4021, bottle lot 60374001/01AH -pink; box lot 2720-4022, bottle lot 60363002/01BE -yellow; box lot 2720-4023, bottle lot 60374001/01AK - pink;  product code 2793, kit box lot 2793-4005, bottle lots 60343002/02AF - green, 27124001/01AF - orange, 60374001/01AJ - pink, 27164001/01AS - red, 60363002/01BD - yellow and 60353005/01AS - blue;  c.2) product 045-052, box lot 53-2720-4044, bottle lot 60343002/02AE - key lime green
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following brands and sizes: || a.1) Ortho-Jet Powder, Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969, product code 1320, 100 g plastic squeeze bottle; || a.2) Biocryl Resin Acrylic, Great Lakes Orthodontics, Ltd., P.O. Box 5111, Towanda, New York 14151-5111, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle; || b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product code 1520, 100 g plastic squeeze bottle; || b.2) Contemporary Colored Assorted Kit, Great Lakes Orthodontics, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit; || c.1) Electric Colored Ortho-Jet Powder, Lang Dental, product code 2720, 100 g plastic squeeze botles and product code 2793, 45 g plastic squeeze bottles/6 per kit; || c.2) Tropical Tones Acrylic Resin, Great Lakes Orthodontics, product code 045-052, 4 oz. plastic squeeze bottle
  • 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