Events

Retiro De Equipo (Recall) de Scorpio Fixed Femoral A/P Sizing Guide

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 Howmedica Osteonics Corp..

¿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
    56931
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0928-2011
  • Fecha de publicación del evento
    2011-01-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95122
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Stryker orthopaedics has become aware that there is a potential for the shoulder screw on the scorpio sizing guide (the "sizing guide") to disassociate from the main body of the instrument.
  • Acción
    Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.

Device

Scorpio Fixed Femoral A/P Sizing Guide
  • Modelo / Serial
    Catalog Number 8001-0313  Lot # RD3N198 & Lot #RD3N200
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including: Australia, Brazil, China, Columbia, France, Greece, India, Italy, Korea, Poland, Singapore, South Africa, and United Kingdom.
  • Descripción del producto
    Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation || The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA