Events

Rappel de Device Recall Restoration Modular Hip System

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 Corp..

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
    52713
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2166-2009
  • Date de mise en oeuvre de l'événement
    2009-06-26
  • Date de publication de l'événement
    2009-09-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-07-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83792
  • 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/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Cause
    The raw material used in the production of the unipolar adaptor sleeve and the restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. as a precaution and due to the potential impact on the mechanical properties of the products, st.
  • Action
    Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Device

Device Recall Restoration Modular Hip System
  • Modèle / numéro de série
    Catalog number: 6276-1-121; REST MOD PROX CONE BODY 21mm +10 28534101 03-Feb-2014 REST MOD PROX CONE BODY 21mm +10 28534101 03-Feb-2014 REST MOD PROX CONE BODY 21mm +10 28534101 03-Feb-2014 REST MOD PROX CONE BODY 21mm +10 28534101 03-Feb-2014 REST MOD PROX CONE BODY 21mm +10 28534101 03-Feb-2014 REST MOD PROX CONE BODY 21mm +10 28534101 03-Feb-2014 REST MOD PROX CONE BODY 21mm +10 28525702 20-Feb-2014 REST MOD PROX CONE BODY 21mm +10 28525702 20-Feb-2014 REST MOD PROX CONE BODY 21mm +10 29054602 23-Feb-2014 REST MOD PROX CONE BODY 21mm +10 29054602 23-Feb-2014 REST MOD PROX CONE BODY 21mm +10 29054601 24-Feb-2014 REST MOD PROX CONE BODY 21mm +10 29054601 24-Feb-2014 REST MOD PROX CONE BODY 21mm +10 28534101 03-Feb-2014 REST MOD PROX CONE BODY 21mm +10 28525702 20-Feb-2014
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Restoration Modular Hip System; Proximal Cone Body; || 21 mm +10 mm; || Not for use with + 16 V40 femoral Head. For Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA