Events

Retiro De Equipo (Recall) de Device Recall Reprocessed Mitek Arthroscopic Wand

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 Sustainability Solutions, 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
    61296
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1204-2012
  • Fecha de inicio del evento
    2009-06-01
  • Fecha de publicación del evento
    2012-03-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107760
  • 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
    On 06/09/2009, stryker sustain ability solutions, formerly ascent healthcare solutions, recalled lots 674201 & 674290 of their reprocessed mitek arthroscopic wand due to the lots not being tested in accordance with the functional test requirement during the time frame of 04/14/09 to 05/25/09.
  • Acción
    Ascent Healthcare Solutions notified their customers by presenting a letter dated June 1, 2009 from an Ascent Representative. The representative was to recover any products that may have been affected. Questions were directed to 1-888-888-3433.

Device

Device Recall Reprocessed Mitek Arthroscopic Wand
  • Modelo / Serial
    Model # 225301 Lot #s: 674201 & 674290 Expiration dates: 04/2012
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA), including the states of: TX, NY, MN, CA, and CT.
  • Descripción del producto
    The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic surgeries. A generator or controller serves as the power unit. Soft tissue ablators are available in a wide range of sizes and angles; some models include thermal or suction functions. || The outer box of the Reprocessed Mitek Arthroscopic Wand is labeled in part: "***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***Contents sterile by EO unless package is opened or damaged.***Reprocessed Device for single use. Reprocessed By Ascent Healthcare Solutions.***Cat #: 225301 MITEK 3.5mm SIDE EFFECT ELECTRODE***Lot #: 674290 Expiration Date: 04/2012***" || Individual pouch labeled in part: "***Cat #: 225301***MITEK 3.5mm SIDE EFFECT ELECTRODE****IFU at www.ascenths.com***Contents: One Expiration Date 04/2012***Lot # 674201 ID# 0***Reprocessed by Ascent Healthcare Solutions Not affiliated with the original manufacturer.***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***"
  • Manufacturer
    Stryker Sustainability Solutions, Inc.

Manufacturer

Stryker Sustainability Solutions, Inc.
  • Dirección del fabricante
    Stryker Sustainability Solutions, Inc., 5307 Great Oak Dr, Lakeland FL 33815-3113
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA