Events

Retiro De Equipo (Recall) de Device Recall FMP Xalt Acetabular Liner

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 Djo Surgical.

¿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
    67468
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1130-2014
  • Fecha de inicio del evento
    2014-02-07
  • Fecha de publicación del evento
    2014-03-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125512
  • 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
    Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. the units labeled as model/catalog number 931-28-248 lot/serial number 685f1034 on the outside and containing model/catalog number 932-36-252, lot# 728f1089 on the inside (1.
  • Acción
    DJO Global sent an Urgent Field Safety Notice dated February 7, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. All 10 devices with the outer label of 931-28-248, Lot#685F1034 were found in-house and were quarantined. The agencies who have the affected product (devices labeled as 932-36-252, Lot# 728F1089 containing 931-28-248, Lot#685F1034) were contacted to quarantine their devices. Of the affected devices, 2 of the lot of 10 have already been returned via product complaint. Customers were instructed to pass on the notice to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. Customers were instructed to place a replacement order and receive an RMA number to return all affected devices.. Customers with questions were instructed to call 512-834-6255.

Device

Device Recall FMP Xalt Acetabular Liner
  • Modelo / Serial
    Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner)  were mistakenly packaged/labeled as  Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner)  and vice-versa
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
  • Descripción del producto
    FMP X-alt Acetabular Liner || This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
  • Manufacturer
    Djo Surgical

Manufacturer

Djo Surgical
  • Dirección del fabricante
    Djo Surgical, 9800 Metric Blvd, Austin TX 78758-5445
  • Source
    USFDA