Events

Retiro De Equipo (Recall) de Device Recall CLAW HEX SCREWS

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 Wright Medical Technology 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
    56091
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2188-2010
  • Fecha de inicio del evento
    2010-06-07
  • Fecha de publicación del evento
    2010-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92620
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    One lot of claw hex foot and ankle screws was incorrectly packaged containing multi-use compression screws.
  • Acción
    The firm initiated their recall to their sales representatives (distributors) via telephone on 06/07/2010 and followed with a letter dated June 15, 2010 sent via Fed Ex on 06/28/2010. The hospital involved was also notified by letter on 06/29/2010. The letter described the product, the problem,and the action to be taken by the customers. The customers were instructed to immediately return any affected product to Wright as soon as possible, and to complete an attached response form confirming receipt of the notice and return a copy by fax to 901-867-7401. Customers may contact customer service for return instructions and replacement inventory at 800-238-7117. If you have any questions regarding this matter, contact Debby Daurer at 800-874-5630.

Device

Device Recall CLAW HEX SCREWS
  • Modelo / Serial
    Item # 40133520 Lot # 0501148499
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution in States of FL, PA, KS, IN, MO, and CA
  • Descripción del producto
    CLAW¿ HEX SCREW CHARLOTTE " F&A; SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT MATERIAL: Stainless Steel Ref: 4013-3520 ... Size 3.5MM, Length 20 MM, Use with Clava¿ 3.5MM - Non-Sterile. Implantation: used in Food and Ankle surgeries.
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Dirección del fabricante
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002
  • Empresa matriz del fabricante (2017)
    Wright Medical Group NV
  • Source
    USFDA