Retiro De Equipo (Recall) de Device Recall Fixion Interlocking Proximal Femoral Intramedullary Nailing System (Fixion PF Nail) Hip Peg

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 Disc Orthopaedic Technologies 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Nail, Fixation, Bone, Metallic - Product Code NDH
  • Causa
    The fixion interlocking proximal femoral hip pegs are defective due to possible tension failure.
  • Acción
    The first letter, dated Monday October 14, 2002, went out to 10 of the firm''s agents who directly handled this line of product. The firm then sent out a follow-up letter, dated Wednesday December 11, 2002, to the same agents that they had previously made contact with to assure their knowledge regarding the recall.


  • Modelo / Serial
    Catalog # Lot # -- 4418080--PF02385;  PF02437;  PF02477;  PF02696;  PF02697;  PF02695;  PF02378;  PF02333;   4408080-- FP-1161;  FP-1094;  FP01176;  FP-1089;   4408081-- PF02333;   4418090-- PF02701;  PF02700;  PF02478;  PF02438;  PF02640;   4408101-- PF02335;   4418105-- PF02336;   4408111-- PF02193;   4418110-- PF02713;  PF02712;  PF02709;  PF02641;  PF02495;  PF02480;  PF02440;  PF02387;  PF02380;   4408110-- FP01175;  FP-1147;  FP-1097;  FP-1092;   4408090-- FP01179;  FP-1163;  FP-1095;  FP-1090;  271201;   4408091-- PF02192;   4418095-- PF02334;   4408100-- FP-1096;  FP-1091;  FP01178;  FP-1160;   4418100-- PF02335;  PF02707;  PF02371;  PF02379;  PF02386;  PF02439;  PF02479;  PF02703;  PF02705;  PF02706;   4418120-- PF02715;  PF02714;  PF02539;  PF02441;  PF02388;  PF02381;  PF02372;  PF02337;   4408120-- FP01177;  FP-1162;  FP-1098;  FP-1093;   4408121-- PF02337.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Product is manufactured at Disc-O-Tech Medical Technologies Ltd. located at 3 Hasadnaot St., Herzliya 46728, Israel. Product is then distributed to the rest of the world including the U.S.A. Products enter the U.S.A. through Port Elizabeth, New Jersey. The firm''s U.S.A. importer and distributor is Disc Orthopaedic Technologies, Inc., located at 101 Interchange Plaza, Cranbury, NJ 08512. Disc Orthopaedic Technologies, Inc., then distributes the product to their Agent Principles, employees of Disc Orthopaedic Technologies, Inc., throughout the U.S.A. Each agent principle then distributes the product to their sales representative who then sells the product to customers, primarily consisting of surgeons. Product is maintained with the sales representative and is only sold to a customer on an as needed basis. Customers do not have stock of product maintained at hospitals. Hospitals are located nationwide.
  • Descripción del producto
    Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110mm, 111mm, 120mm, and 121mm. The Fixion PF Hip Peg is intended for use in the fixation of proximal fractures in the femur.
  • Manufacturer


  • Dirección del fabricante
    Disc Orthopaedic Technologies Inc, 101 Interchange Plaza, Cranbury NJ 085123716
  • Source