Events

Retiro De Equipo (Recall) de Disposable Paper Filter for Containers

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 Stryker Craniomaxillofacial Division.

¿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
    72170
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0114-2016
  • Fecha de inicio del evento
    2015-09-17
  • Fecha de publicación del evento
    2015-10-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140151
  • 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
    Tray, surgical, instrument - Product Code FSM
  • Causa
    Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.
  • Acción
    An Urgent Medical Device Recall letter has been sent to the customers. The affected product was identified, as well as the reason for the recall and risk to health. The letter states that customers should inform users of the Medical Device Removal and pass the notice to all appropriate individuals within the organization; scrap all affected products available at the location or return it to Stryker Craniomaxillofacial, Attention: Recall Coordinator, at the address provided. If there are questions regarding the impacted product, don't hesitate to Contact Stryker Customer service and refer to PFA #2015-032. Complete and sign the enclosed Business Reply Form and fax or copy to: (877) 648-7114 or e-mail a copy to CMF-custserv@stryker.com.

Device

Disposable Paper Filter for Containers
  • Modelo / Serial
    Part Number:  29-10911 Disposable Paper Filter for Sterilization Container, 30x29cm, new type (P/100);  29-10912 Disposable Paper Filter for Sterilization Container, 60x 29cm, old type (P/100), obsolete (Part not distributed in the US);  29-10913 Dispoable Paper Filter for Sterilization Container, 60x29cm new type (P/100) (Part not distributed in the US);  29-10915 Disposable Paper Filter, 4-holes, for Coiner (Part not distributed in the US)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
  • Descripción del producto
    Disposable Paper Filter for Sterilization Containers || Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

Stryker Craniomaxillofacial Division
  • Dirección del fabricante
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way, Ste 200, Portage MI 49002-0482
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA