Events

Retiro De Equipo (Recall) de Device Recall Pinnacle Cancellous 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 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
    62764
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0569-2013
  • Fecha de inicio del evento
    2012-11-28
  • Fecha de publicación del evento
    2012-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111672
  • 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, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Causa
    Depuy orthopaedics, inc. is issuing a voluntary recall of ten lots of the pinnacle¿ cancellous screw due to an incorrect description on the label. the label description reads pinnacle cannulated screw and should read pinnacle cancellous screw.
  • Acción
    The firm, DePuy Orthopedics, Inc., sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" dated July 2012 to its customers via email and mail. The notice described the product, problem and actions to be taken. The customers were instructed to determine whether they would like to retain and use the product or return affected product to DePuy in Warsaw, IN, and to complete and return the Reconciliation forms to your DePuy Sales Representative or by fax to: 574-371-4939. DePuy sales representatives are expected to aid customers in returning of recalled products. For questions about recall information provided, please contact the Manager, Post-Market Surveillance, 574-372-7333 (M-F; 8 am - 5 pm EDT.)

Device

Device Recall Pinnacle Cancellous Screw
  • Modelo / Serial
    Catalog number: 121708500 and Lot numbers: 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution: USA states of: GA, MA, MN, SC and VA.
  • Descripción del producto
    Pinnacle Cancellous Screw || Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. || PINNACLE¿ CANCELLOUS Bone Screws are ancillary fixation devices used in total hip arthroplasties. These screws are used to secure PINNACLE ACETABULAR Shell implants to the acetabulum via screw holes designed in the shell. Intended Use: This product is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures.
  • 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