Events

Retiro De Equipo (Recall) de Device Recall Triathlon Femoral Distal Augment Left

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
    64941
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1370-2013
  • Fecha de inicio del evento
    2013-03-25
  • Fecha de publicación del evento
    2013-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117473
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Stryker orthopaedics received a report that a label on the external packaging (box) of a triathalon femoral distal augment 10mm- size 5 left depicted a glyph of an acetabular shell rather than a femoral distal augment. in addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.
  • Acción
    The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 25, 2013 and Product Accountability Forms via Fed Ex to its Consignees/ customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the attached Notification Acknowledgment Form within 5 days via fax to 855-251-3635; contact the hospitals in your territory that have the affected product to arrange return of product; and return affected product to the attention of Regulatory Compliance Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, attach flourescent orange PRODUCT REMEDIATION sticker to your return indicating the PR #RA2013-011 and mark outer box with the words "Product Recall". If you have any questions, feel free to contact Manager, Divisional Regulatory Compliance at (201) 972-2100.

Device

Device Recall Triathlon Femoral Distal Augment Left
  • Modelo / Serial
    Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.
  • Descripción del producto
    Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package || Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA || Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 || Meyzieu, Cedex, France || This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone
  • 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