Events

Retiro De Equipo (Recall) de Device Recall DePuy Spine

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 DePuy 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
    58271
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2103-2011
  • Fecha de inicio del evento
    2011-03-22
  • Fecha de publicación del evento
    2011-04-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98846
  • 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 channeling instrument, vertebroplasty - Product Code OCJ
  • Causa
    Mislabeled: package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle.
  • Acción
    The firm, DePuy Spine, sent an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" letter dated March 22, 2011 to its consignees/customers ( hospital sites and domestic sales distributors). A product reconciliation form was provided to assist in the retrieval of affected product. The letter described the product, problem and actions to be taken. The customers were instructed to return any needles that they may have to their local Distributor for DePuy Spine products and complete and return the Product Reconciliation Form via fax to 508-828-3762; call Customer Service at 877-379-4871 to receive a return goods authorization number and/or mail the form with the return product to DePuy Spine Inc., 50 Scotland Boulevard, Bridgewater, MA 02324, Attn: CONFIDENCE NEEDLE RECALL COORDINATOR, RGA #. If you have any questions or concerns with regard to this notice, please contact the DePuy Spine Regulatory Compliance Department at 508-828-2790.

Device

Device Recall DePuy Spine
  • Modelo / Serial
    Lot Code: HLPB4F
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of: AZ, IA, LA, TX, NE, NJ ,NY, PA, VA, and WA; and countries of: Canada, Australia, Belgium, France,Hungary, Italy, Malaysia, Solvenia, UK, South Africa, Switzerland, and UAE.
  • Descripción del producto
    Confidence¿ Introducer Needle Side Hole 13G x 4-Inch || Product Code: 2839-04-413 || The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw.
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Dirección del fabricante
    DePuy Spine, Inc., 325 Paramount Drive, Raynham MA 02767
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA