Events

Retiro De Equipo (Recall) de Device Recall Altrx" Altralinked" Polyethylene liners

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
    62649
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2220-2012
  • Fecha de inicio del evento
    2012-07-24
  • Fecha de publicación del evento
    2012-08-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111266
  • 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
    In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. this resulted in a size 52 liner being etched and labeled as a size 54 liner.
  • Acción
    Depuy sent an URGENT MEDICAL DEVICE RECALL notification dated July 24, 2012, to all affected consignees. The recall is extended to the Depuy Distributor level and hospital level. All DePuy Distributors were notified via email. The sales representatives notify the hospital either by mail or in person with a written communication. Distributors and customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN. The sales representatives are expected to aid customer in returning of recalled products. Distributors and sales representatives are to return the recalled products through the normal DePuy Returns process, to attention of Returns and marking H12-16 on the outside of the box. Reconciliation forms should be returned to the DePuy Sales Representative or faxed to 574-372-7567. For clinical questions from Surgeons contact DePuy's Scientific Information Office at 1-888-554-2482. For questions regarding recall information call 574-372-7333.

Device

Device Recall Altrx" Altralinked" Polyethylene liners
  • Modelo / Serial
    Catalog number: 1221-36-054 and Lot Number: 231859
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including PA and the country of Canada
  • Descripción del producto
    Altrx" Altralinked" Polyethylene liners || Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • 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