Events

Retiro De Equipo (Recall) de Device Recall Stryker Howmedica Osteonics

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
    67055
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0849-2014
  • Fecha de inicio del evento
    2013-11-07
  • Fecha de publicación del evento
    2014-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124623
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product teflon tube, sterile.
  • Acción
    The firm, Stryker, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 17, 2013 to its customers via e-mail. Preliminary notification letters and Product Accountability Forms were sent via FedEx on November 15, 2013 with return receipt to the Stryker locations. Notification and Product Accountability Forms were sent 12/18/2013 via Fed Ex with return receipt. Updated letters were sent via Fed Ex on 12/19/2013 with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine affected devices in local inventory as well as retrieve any devices located in hospitals; inform users of the Medical Device Removal and pass this to all those individuals who need to be aware within your organization; return all affected products available to your location to: Stryker Osteosynthesis, c/o Colleen O'Meara, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ, 07430, REF: PFA#2013-168 or contact Stryker customer service and refer to PFA #2013-166 for returning the product to us; complete and return the enclosed Business Reply Form and fax a copy to: 1-865-251-3635 or email a copy to Recall Coordinator at aminah.crawford@stryker.com, and keep a copy of the completed and executed Business Reply form for your records. If you have any further questions, contact Manager, Regulatory Compliance at 1-201-972-2100 or email: colleen.omeara@stryker.com.

Device

Device Recall Stryker Howmedica Osteonics
  • Modelo / Serial
    Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.
  • Descripción del producto
    Teflon Tube, sterile || T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 || 24232 Sconkidrchen, Germany || distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA || 510 K042396 || Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA