Events

Retiro De Equipo (Recall) de Alpen Carbide 702 Cross Cut Tapered Fissure

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 Coltene Whaledent 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
    79994
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1883-2018
  • Fecha de inicio del evento
    2018-04-13
  • Fecha de publicación del evento
    2018-05-14
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164149
  • 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
    Bur, dental - Product Code EJL
  • Causa
    The products are labeled with an incorrect product number.
  • Acción
    Customers were contacted via telephone call on 4/13/18. The customers were asked the following questions: 1. Confirm that {name of Distributor} received {number of packs} around this date {date}. 2. Confirm that the affected product, lot number I37460, is still in their inventory. a. If not, to whom was it shipped to? [Coltene will need that contact information]. 3. Can you take a picture of the lot number I37460 that you received and send to {Regional sales manager}? 4. Please return the product in question to Coltene per Vendor Return Authorization with full tracking information.

Device

Alpen Carbide 702 Cross Cut Tapered Fissure
  • Modelo / Serial
    Batch I37640
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
  • Descripción del producto
    Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
  • Manufacturer
    Coltene Whaledent Inc

Manufacturer

Coltene Whaledent Inc
  • Dirección del fabricante
    Coltene Whaledent Inc, 235 Ascot Pkwy, Cuyahoga Falls OH 44223-3701
  • Empresa matriz del fabricante (2017)
    Coltene Holding AG
  • Source
    USFDA