Events

Retiro De Equipo (Recall) de Device Recall Stryker Orthopaedics Bone Screw

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-2127-2009
  • 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=83752
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in astm standard for titanium surgical implants.
  • 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 Stryker Orthopaedics Bone Screw
  • Modelo / Serial
    Catalog number: 2029-5525-1; 5.5 CANCELLOUS BONE SCREW 25mm N0PMKE 24-Jun-2013 5.5 CANCELLOUS BONE SCREW 25mm N0NMKE 24-Jun-2013 5.5 CANCELLOUS BONE SCREW 25mm N0MMKE 24-Jun-2013 5.5 CANCELLOUS BONE SCREW 25mm N0RMKE 25-Jun-2013 5.5 CANCELLOUS BONE SCREW 25mm H1NMLE 21-Jul-2013 5.5 CANCELLOUS BONE SCREW 25mm JLWMLE 23-Jul-2013 5.5 CANCELLOUS BONE SCREW 25mm EL5MME 24-Aug-2013 5.5 CANCELLOUS BONE SCREW 25mm EMVMME 24-Aug-2013 5.5 CANCELLOUS BONE SCREW 25mm KW8MME 24-Aug-2013 5.5 CANCELLOUS BONE SCREW 25mm EL6MME 25-Aug-2013 5.5 CANCELLOUS BONE SCREW 25mm MER1AN 11-Nov-2013 5.5 CANCELLOUS BONE SCREW 25mm MER1AM 12-Nov-2013 5.5 CANCELLOUS BONE SCREW 25mm MET3JH 10-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET3JE 11-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET6KM 14-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET6AR 14-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET6KL 14-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET6LL 14-Dec-2013
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Stryker Orthopaedics Cancellous Bone Screw; || Dia 5.5 mm; Lnth: 25 mm; Sterile: || Made in the USA; || Stryker Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430. || The bone screws are optional fixtures that may be used during knee and hip replacement procedures.
  • 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