Events

Rappel de Device Recall Stryker Howmedica Osteonics Corp.

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
    63442
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0469-2013
  • Date de mise en oeuvre de l'événement
    2012-07-27
  • Date de publication de l'événement
    2012-12-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113917
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Offset bushings associated with the lots identified were mismarked: the rotational reference numbers on the tibial offset bushing were marked counterclockwise instead of clockwise; the femoral offset bushing did not include rotational markings.
  • Action
    Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated July 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Acknowledgement Form was attached for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-972-2100 for assistance with this recall.

Device

Device Recall Stryker Howmedica Osteonics Corp.
  • Modèle / numéro de série
    Class I, 510(k) exempt  Catalog Number: 6543-1-600  Lot Number; NE1WR1
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Stryker Orthopaedics || FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS || REF 6543-1-600;NON-STERILE || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || A Subsidiary of Stryker Corp. || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green 69881 Meyzieu || Cedex France || The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. || Made in USA
  • 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