Events

Retiro De Equipo (Recall) de Device Recall SIGMA LCS HIGH PERFORMANCE"

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
    66864
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0423-2014
  • Fecha de inicio del evento
    2013-11-18
  • Fecha de publicación del evento
    2013-11-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123821
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Depuy orthopaedics, inc. is issuing a voluntary device correction of the hp m.B.T. keel punch knee instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
  • Acción
    DePuy Orthopaedics sent an Urgent Information - Medical Device Correction letter to all affected customers on November 18, 2013. Immediately after initiation on November 18, the company halted initiation with our US distributors and international affiliates because the surgical technique referenced and images from the surgical technique were not correct. No surgeons received the November 18 surgeon letter. The recall was re-initiated on November 20, 2013. The communication to the surgeons who used the affected devices will be delivered by Distributors either by mail or in person and includes the surgeon letter. The device correction includes awareness, reiteration of surgical techniques and instrument care, and visual check of the device as outlined in the Field Notice and Surgeon letter. The devices are not being removed from the market, but the company is investigating potential design changes to the HP M.B.T. Keel Punch Knee Instrument to reduce the potential for the tabs to fracture. All DePuy United States Distributors and DePuy affiliate contacts for Canada, Latin America and International will be notified via email. The US Distributors will identify surgeons who use the affected instruments on Distributor Response Card #1. The US Distributor will notify surgeons either by mail or in person with the written communication. Once all device correction activities are complete, the US Distributor will complete and return Distributor Card #2 to DePuy Orthopaedics, Inc. The US distributors are the US consignees and are responsible for notifying all new HP M.B.T. Keel Punch Knee Instrument surgeon users of this device correction. All territories are required to ensure the HP M.B.T. Keel Punch Knee Instrument Device Correction is promptly initiated. Customers were asked to review the instructions included, along with the attached documents, which contain important information regarding notification of surgeons affected by this Device Correction. Customers

Device

Device Recall SIGMA LCS HIGH PERFORMANCE"
  • Modelo / Serial
    Item #950502021
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
  • Descripción del producto
    SIGMA¿ LCS¿ HIGH PERFORMANCE" || MBT PUNCH NONCEMENTED || Size 4-7 || HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
  • 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