Events

Retiro De Equipo (Recall) de Device Recall Collarless Cementless Hip Stem

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
    79024
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0594-2018
  • Fecha de inicio del evento
    2017-07-12
  • Fecha de publicación del evento
    2018-02-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161203
  • 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, hemi-, femoral, metal - Product Code KWL
  • Causa
    Incorrect device in the package. a package that was labeled as the corail coxa vara high offset stem collared size 9 (part no. 3l93709 / lot no. 5291990), contained the corail high offset stem collarless size 14 (part no. l20314 / lot no. 5292130).
  • Acción
    In August of 2017 customers were notified via an Urgent Medical Device Recall Letter, titled "ONE LOT OF CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 and ONE LOT OF CORAIL HIGH OFFSET STEM Collarless SIZE 14" with instructions to cease using the affected product immediately. Note: The affected devices may be on consignment at your facility. Return Affected Implants: Determine if any of the recalled devices are still on hand and return the affected device(s) immediately to the DePuy Sales Consultant or return to DePuy Synthes for credit following the normal returns procedures. Reconciliation Form: Complete the Reconciliation Form and return to your DePuy Orthopaedics Sales Consultant or fax to 574-371-4939 or scan and email to DPYUS-JointReconFieldActions@its.jnj.co Records: Retain a copy of the completed Reconciliation Form in your files along with this notice. Additional Notifications: Notify surgeon users at your facility by providing them with a copy of this notice to ensure surgeon users are aware of this recall. Forward this notice to others in your facility that need to be informed. If any affected product has been forwarded to another facility, contact that facility immediately to communicate this field action with the facility/facilities. Maintain a copy of this notice with the affected devices. Contacts For product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific and Medical Affairs mailbox RA-DPYUS-DePSynSc@ITS.JNJ.com. For questions about device recall information provided, please contact Kim (Earle) Long, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m.  5 p.m. EDT) or at DPYUS-JointReconFieldActions@its.jnj.com. Health care professionals may report serious adverse events, side effects or product quality problems with the use of this product to DePuy Orthopaedics, Inc. either by contacting yo

Device

Device Recall Collarless Cementless Hip Stem
  • Modelo / Serial
    Part No. L20314 and Lot No. 5292130
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device.
  • Descripción del producto
    CORAIL HIGH OFFSET STEM Collarless SIZE 14
  • 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