Events

Retiro De Equipo (Recall) de Device Recall XIA 3 Polyaxial 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 Spine.

¿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
    54271
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0823-2010
  • Fecha de inicio del evento
    2009-12-30
  • Fecha de publicación del evento
    2010-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88077
  • 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
    Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease - Product Code NKB
  • Causa
    The xia 3 8.5mm polyaxial screws, lot a91109 were anodized turquoise instead of fuchsia. the turquoise color is reserved for the 9.5 mm xia 3 screws.
  • Acción
    Stryker Spine branches that received the recalled product were notified of the recall by an Urgent Product Recall letter, dated January 15, 2010, sent via Federal Express. The letter identified the affected product and the issue involved. It also discussed the potential hazards, risk mitigation, and the return process. Customers are to examine their inventory and hospital locations to identify the product. Customers are also to reconcile the product by utilizing the Customer Response Form and distribution sheet. In addition, they are to retrieve and return the affected product. Questions should be directed to Tiffani Rogers at 201-760-8206.

Device

Device Recall XIA 3 Polyaxial Screw
  • Modelo / Serial
    Lot number: A91109
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution -- IL, MO, DA, MA and CO.
  • Descripción del producto
    Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. || Not Sterile; || Manufactured by Stryker Spine, SA, Cestas, France. || Distributed in the USA by Stryker Spine, Allendale, NJ || Intended for use in the noncervical spine.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Dirección del fabricante
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA