Events

Retiro De Equipo (Recall) de Device Recall OrthoJet Powder

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Lang Dental Mfg Co, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    29304
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1042-04
  • Fecha de inicio del evento
    2004-06-07
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-09-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33516
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Crown And Bridge, Temporary, Resin - Product Code EBG
  • Causa
    The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
  • Acción
    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
  • Modelo / 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
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    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.
  • Dirección del fabricante
    Lang Dental Mfg Co, Inc., 175 Messner Dr, Wheeling IL 60090-6433
  • Source
    USFDA