Events

Retiro De Equipo (Recall) de Device Recall Henry Schein Explorer Double End 5

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 Hu-Friedy 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
    30882
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0528-05
  • Fecha de inicio del evento
    2005-01-07
  • Fecha de publicación del evento
    2005-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36764
  • 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
    Explorer, Operative - Product Code EKB
  • Causa
    Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
  • Acción
    Hu-Friedy Mfg. Co., Inc. notified the Own Label Distributor of the recall on 1/7/05 by phone, and in writing on 1/10/05. Henry Schein, Inc. is having formal "URGENT: DEVICE RECALL" letters printed up which will be mailed to over 8100 of Schein's direct customers by First Class Mail on/about 1/21/05 to initiate the sub-recall of the dental explorers. Henry Schein will follow-up to non-responders by phone and/or fax.

Device

Device Recall Henry Schein Explorer Double End 5
  • Modelo / Serial
    Date Codes/Lot Numbers: 0503, 0603, 0903, 1003, 1103. Barcode +H658100800808.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Dental practitioners, hospitals, dental clinics and distributors located nationwide, in Puerto Rico and internationally.
  • Descripción del producto
    Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN¿ 100-8008 Explorer-Double End #5. +H658100800808. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).
  • Manufacturer
    Hu-Friedy Mfg Co, Inc.

Manufacturer

Hu-Friedy Mfg Co, Inc.
  • Dirección del fabricante
    Hu-Friedy Mfg Co, Inc., 3232 N Rockwell St, Chicago IL 60618-5944
  • Source
    USFDA