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
  • 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
  • 1 Event

Manufacturer

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