Events

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

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Disc Orthopaedic Technologies Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    25800
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0943-03
  • Date de mise en oeuvre de l'événement
    2002-12-11
  • Date de publication de l'événement
    2003-06-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2003-04-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26491
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Nail, Fixation, Bone, Metallic - Product Code NDH
  • Cause
    The fixion interlocking proximal femoral hip pegs are defective due to possible tension failure.
  • Action
    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.

Device

Device Recall Fixion Interlocking Proximal Femoral Intramedullary Nailing System (Fixion PF Nail...
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
    Disc Orthopaedic Technologies Inc

Manufacturer

Disc Orthopaedic Technologies Inc
  • Adresse du fabricant
    Disc Orthopaedic Technologies Inc, 101 Interchange Plaza, Cranbury NJ 085123716
  • Source
    USFDA