Events

Retiro De Equipo (Recall) de AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor.

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 Tornier, 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
    66057
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2199-2013
  • Fecha de inicio del evento
    2013-08-13
  • Fecha de publicación del evento
    2013-09-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121387
  • 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
    Instrument, cutting, orthopedic - Product Code HTZ
  • Causa
    Following the identification of the disassociation of an impactor tip during surgery, tornier is initiating a voluntary recall of all lots of aequalis reversed ii and reversed fracture impactors. upon review of the event, tornier determined that a redesign of the instrument was warranted. these products are contained within the aequalis revered ii instrument set tray no ykad83 and the aequalis r.
  • Acción
    Tornier sent an "Urgent Medical Device Recall" letter dated August 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were advised to cease further use and distribution of the product and to contact all end users. Also requested the completion and return of the attached questionnaire via fax to 952-236-4007, e-mail to CustomerServices@Tonier.com or using the envelope provided. We apologize for the incovenience and thank you in advance for your cooperation in this matter. If you have any questions please contact our Customer Service Department at 1-888 494-7950.

Device

AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor.
  • Modelo / Serial
    all lots
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    .Worldwide Distribution - USA including Puerto Rico and the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN, NE, NJ, NC, OH, OR, PA and TX., and the countries of CANADA, MEXICO, HONG KONG, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NETHERLANDS, SLOVENIA, SPAIN, SWITZERLAND and UNITED KINGDOM
  • Descripción del producto
    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. || The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.
  • Manufacturer
    Tornier, Inc

Manufacturer

Tornier, Inc
  • Dirección del fabricante
    Tornier, Inc, 10801 Nesbitt Ave S, Bloomington MN 55437-3109
  • Empresa matriz del fabricante (2017)
    Wright Medical Group NV
  • Source
    USFDA