Events

Retiro De Equipo (Recall) de Device Recall LPS Diaphyseal Sleeves

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 Orthopaedics, 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
    63783
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0831-2013
  • Fecha de inicio del evento
    2013-01-04
  • Fecha de publicación del evento
    2013-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114766
  • 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
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Causa
    Depuy orthopaedics is initiating a voluntary recall of the lps diaphyseal sleeve because the product has the potential for fracture at the taper junction. the lps diaphyseal sleeve to diaphyseal sleeve base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
  • Acción
    DePuy Othopaedics sent an Urgent Information Medical Device Recall Notice letter dated January 4, 2013 to all affected customers. The letter identified the affected products, reason for recall, clinical implications and actions to be taken. The letter instructed customers to check inventory, discontinue use, cease further distribution and return all inventory on hand for credit. Customers were requested to complete and return the Reconciliation Form. For product-related questions contact your local DePuy Othopaedics Sales Representative, clinical questions contact DePuy's Scientific Information Office at 1-888-554-2482 and recall notice information call 574-372-7333.

Device

Device Recall LPS Diaphyseal Sleeves
  • Modelo / Serial
    Part number: 198720028 and Lot numbers: 123510, 156211, 212355, B34GG1000, B4TH51000, B5RAX1000, B5RAXA000, B5RAXB000, CC3KX1000, CC3KXA000, E4RF31000, E4RF3A000, E55HV1, and EN4KN1000.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.
  • Descripción del producto
    LPS Diaphyseal Sleeves || Product Usage: || The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Dirección del fabricante
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA