Events

Retiro De Equipo (Recall) de Device Recall Stryker

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 Endoscopy.

¿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
    62346
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1961-2012
  • Fecha de inicio del evento
    2012-06-19
  • Fecha de publicación del evento
    2012-07-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110301
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    The gravity steam, ethylene oxide (eo) and sterrad 100s sterilization methods are being removed from the "instructions for use"; due to the firm's evaluation that identified original validation was not done at worst case conditions.
  • Acción
    Stryker Endoscopy sent a Urgent Device Correction letter dated June 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to: 1. Discard any old Instructions for Use for your Arthroscope and Hardware Set Tray. 2. Download the new IFU from the URL link: http://stryker.com/arthrotray . Complete and sign the enclosed acknowledgement of receipt form and fax to (408) 754-8378 or scan in and email to trays@stryker.com.* It is important to send the self addressed confirmation form back to Stryker. Stryker is committed to delivering the highest quality products to its customers. We sincerely apologize for any inconvenience this action may cause. If you have any questions regarding this letter please contact us at 1-800-624-4422 or via email at trays@stryker.com. .

Device

Device Recall Stryker
  • Modelo / Serial
    All serial/lot numbers
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide)
  • Descripción del producto
    Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA || The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Dirección del fabricante
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA