Events

Retiro De Equipo (Recall) de Device Recall Nobel Replace Tapered Groovy RP 4.3x10mm

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 Nobel Biocare USA LLC.

¿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
    48702
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2240-2008
  • Fecha de inicio del evento
    2007-11-02
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-09-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71930
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Causa
    This recall was initiated after it was discovered that the nobelreplace tapered groovy rp 4.3x10mm, ref 32216 lot#403504 has an incorrect cap label. the affected lot has a cap label identifying the implant as "4.3x8". since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the 10mm implant as an 8mm implant.
  • Acción
    The recall was initiated on 11/02/2007 with telephone calls to the affected customers. A "Urgent Medical Device Recall" letter with attached Customer Response form was then sent via US Postal Service beginning on 11/02/2007. The letter instructed customers to please immediately remove and return REF 32216 Lot #403504, NobelReplace Tapered Groovy RP 4.3x10mm. The firm contracted UPS courier service to pick up the recalled products. Customers were also instructed if the have further distributed the affected product to please immediately notify those customer to cease using this particular lot and forward the customer this notice. The firm indicated in the recall notice that they are in the process of sending out replacement products. Contact Kam Leung at 714-282-4800 if you have questions.

Device

Device Recall Nobel Replace Tapered Groovy RP 4.3x10mm
  • Modelo / Serial
    Ref 32216 lot number: 403504
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    AR, AZ, CA, CO, FL, GA, IA, IL, MA, ME, MI, MO, NC, NC, NJ, NY, OK, PA, TX, UT, VA, WA
  • Descripción del producto
    NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.
  • Manufacturer
    Nobel Biocare USA LLC

Manufacturer

Nobel Biocare USA LLC
  • Dirección del fabricante
    Nobel Biocare USA LLC, 22715 Savi Ranch Pkwy, Yorba Linda CA 92887-4609
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA