Events

Retiro De Equipo (Recall) de T2 Humerus Sterile Teflon Tube

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
    63457
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0610-2013
  • Fecha de inicio del evento
    2012-08-06
  • Fecha de publicación del evento
    2012-12-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113931
  • 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
    During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the t2 humerus teflon tube.
  • Acción
    The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter & Acknowledgement form dated August 7, 2012 via FedEx Return Receipt to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to inform their users of this Medical Device Removal and pass this notice to all those individuals who need to be aware within their organization; return all affected products available at their location to: Stryker Osteosynthesis, 325 Corporate Drive, Mahwah, NJ 07430 REF: PFA#2012-124 or contact Stryker customer service; complete and sign the enclosed Product Recall Acknowledgement Form and Fax to 1-855-251-3635 or email to Recall Coordinator at janice.pevide@stryker.com and keep a copy of their records. If you have any questions, contact the Manager, Regulatory Compliance, at 1-201-972-2100 or email: colleen.omeara@stryker.com.

Device

T2 Humerus Sterile Teflon Tube
  • Modelo / Serial
    Catalog No: 1806-0073S  Lot Code:123596
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AL, CO, CT, IL, IN, MO, MS, NC, NJ, NY, OR,and TX; and countries of: Australia, Canada, France, Spain and United Kingdom.
  • Descripción del producto
    Stryker Howmedica Osteonics; Stryker T2 Humerus System || Teflon Tube, sterile; REF 1806-0073S || The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. || Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany || distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive,
  • 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