Events

Retiro De Equipo (Recall) de Device Recall Restoration Modular Hip System

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
    52713
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2167-2009
  • Fecha de inicio del evento
    2009-06-26
  • Fecha de publicación del evento
    2009-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83793
  • 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
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Causa
    The raw material used in the production of the unipolar adaptor sleeve and the restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. as a precaution and due to the potential impact on the mechanical properties of the products, st.
  • Acción
    Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Device

Device Recall Restoration Modular Hip System
  • Modelo / Serial
    Catalog number: 6276-1-123; REST MOD PROX CONE BODY 23mm +10 28716401 20-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716401 20-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716401 20-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716401 20-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705602 22-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716402 23-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705603 22-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705603 22-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716402 23-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716402 23-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705602 22-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716402 23-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716402 23-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705501 27-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705501 27-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705601 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705601 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705601 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705601 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28705601 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716403 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716403 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716403 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716403 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716403 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716403 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716403 28-Jan-2014 REST MOD PROX CONE BODY 23mm +10 28716404 10-Mar-2014 REST MOD PROX CONE BODY 23mm +10 28716404 10-Mar-2014 REST MOD PROX CONE BODY 23mm +10 28716404 10-Mar-2014 REST MOD PROX CONE BODY 23mm +10 28941001 09-Mar-2014
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Restoration Modular Hip System; Proximal Cone Body; || 23 mm +10 mm; || Not for use with + 16 V40 femoral Head. For Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
  • 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