Events

Retiro De Equipo (Recall) de Device Recall BONELOK PLS Implant

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
    58381
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3034-2011
  • Fecha de inicio del evento
    2011-03-15
  • Fecha de publicación del evento
    2011-08-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99410
  • 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
    System, facet screw spinal device - Product Code MRW
  • Causa
    This recall has been initiated due to pull pins that may disengage from the facet screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain.
  • Acción
    Interventional Spine, Inc. sent a recall letter dated March 15, 2011, informing consignees of the product, the problem, and the action to be taken. Consignees were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if they distributed the product further they were asked to notify Jane Metcalf, the Vice President of Quality Assurance at once. Interventional Spine further informed consignees that the recall was being carried out to the individual consignee level. And their assistance was appreciated and necessary to prevent use of this product. They were then asked to complete and return the enclosed response form as soon as possible. Questions were directed to call their regional directors. For questions regarding this recall call 949-472-0006.

Device

Device Recall BONELOK PLS Implant
  • Modelo / Serial
    CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0,  CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI
  • Descripción del producto
    Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant || A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.
  • 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