Events

Rappel de Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components.

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 Stryker Howmedica Osteonics.

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
    25460
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0587-03
  • Date de mise en oeuvre de l'événement
    2003-01-07
  • Date de publication de l'événement
    2003-02-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2003-07-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25872
  • 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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
  • Cause
    Some components have disassociated post-operatively resulting in additional surgery to the patient.
  • Action
    Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.

Device

Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, ste...
  • Modèle / numéro de série
    Catalog No. Lot No. Description  6485-3-000 D6MR MRS SML FEM STEM 10 X 102; 6485-3-011 D6CEB MRS 11MM X 127MM FEMORAL STEM; 6485-3-013 D6CFB MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6CFG MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6CFE MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6GZE MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6GZC MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAB MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAC MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAD MRS 13MM X 127MM FEMORAL STEM; 6485-3-015 D6CHD MRS 15MM X 127MM FEMORAL STEM; 6485-3-017 D6BZC MRS 17MM X 127MM FEMORAL STEM; 6485-3-017 D6GPA MRS 17MM X 127MM FEMORAL STEM; 6485-3-017 D6GPD MRS 17MM X 127MM FEMORAL STEM; 6485-3-311 D6CAB MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6CAA MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6GTA MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6GTB MRS 11MM X 203MM FEMORAL STEM; 6485-3-313 D6CBC MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6CBD MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6CBB MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6GWB MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6GWC MRS 13MM X 203MM FEMORAL STEM; 6485-3-317 D6GM MRS 17MM X 203MM FEMORAL STEM; 6485-6-409 D6HMA MRS 9MM TIBIAL STEM; 6485-6-411 D5XWB MRS 11MM TIBIAL STEM; 6485-6-411 D6HNA MRS 11MM TIBIAL STEM;
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
  • Description du dispositif
    Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components.
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • Adresse du fabricant
    Stryker Howmedica Osteonics, 300 Commerce Court, Mahwah NJ 07430
  • Source
    USFDA