Events

Retiro De Equipo (Recall) de Device Recall CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach H

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
    57292
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0815-2011
  • Fecha de inicio del evento
    2010-11-01
  • Fecha de publicación del evento
    2010-12-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95764
  • 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
    The cuttingedge advantage rasp handle, straight rasp handle, and specialty head center accolade broach handle may fracture in two pieces along the width of the body under the striking plate. this may extend surgical time under anesthesia, cause trauma to the surgeon or patient, or contaminate the surgical site.
  • Acción
    Stryker issued a Product Correction Bulletin dated November 2010 to their consignees, alerting surgeons of the need to inspect the instruments before and after each surgical use, and, if a defect is detected, to contact Stryker for return of the product. Stryker can be contacted at 201 831-5288 concerning this issue. In response to their revised strategy, Stryker issued notification letters and product recall acknowledgement forms to their branches and agencies on 2/17/2011 for 2/18/2011 delivery via Fed Ex and to their hospital risk managers on 2/18/2011 for 2/21/2011 delivery via Fed ex.

Device

Device Recall CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center...
  • Modelo / Serial
    CuttingEdge Advantage Rasp Handle - Catalog number 1100-1000; All lot codes  Straight Rasp Handle - Catalog number 1440-1400; All lot codes  Specialty Head Center Accolade Broach Handle - Catalog number I-H088HF00, I-H1389HF00 ; All lot codes
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Throughout the US, the countries of Canada and Japan, and the regions of Asia Pacific, Europe, Middle East, Africa, and Latin America.
  • Descripción del producto
    CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430;
  • 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