Events

Retiro De Equipo (Recall) de Device Recall PERPOS PLS SYSTEM

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 Interventional Spine Inc.

¿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
    58465
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2719-2011
  • Fecha de inicio del evento
    2011-03-23
  • Fecha de publicación del evento
    2011-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99408
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Causa
    This recall has been initiated due to k-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. removing the k-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw.
  • Acción
    Interventional Spine sent an RECALL NOTIFICATION letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to take the following actions: Immediately examine inventory and quarantine product subject to recall. In addition, if this product was further distributed, please notify the Vice President Quality Assurance at once. Consignee were asked to also complete and return the enclosed response form as soon as possible. Consignee with questions were directed to the Consignees' Regional Director or the Vice President Quality Assurance. For further questions, please call (949) 472-0006

Device

Device Recall PERPOS PLS SYSTEM
  • Modelo / Serial
    LOT #'s: 040209-B, 041309-B
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of to NC, NY, TN & VA
  • Descripción del producto
    PERPOS PLS SYSTEM, CATALOG NO. 9045-02 || A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.
  • Manufacturer
    Interventional Spine Inc

Manufacturer

Interventional Spine Inc
  • Dirección del fabricante
    Interventional Spine Inc, 13700 Alton Pkwy Ste 160, Irvine CA 92618-1618
  • Empresa matriz del fabricante (2017)
    Interventional Spine Inc.
  • Source
    USFDA