Events

Rappel de Restoration HA Reduced Neck

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
    61338
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1677-2012
  • Date de mise en oeuvre de l'événement
    2011-10-27
  • Date de publication de l'événement
    2012-05-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107822
  • 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, uncemented, metal/polymer, non-porous, calcium-phosphate - Product Code MEH
  • Cause
    An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.
  • Action
    Stryker sent an "URGENT PRODUCT RECALL" letter dated October 27, 2011 and October 28, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs the customers to return the product to the firm. An Acknowledgement Form was included for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.

Device

Restoration HA Reduced Neck
  • Modèle / numéro de série
    510(K) #K951671 Catalog #: S-2653-0812-L Affected Lot Codes 45041401 49051101 50024801 21578001 26464501A 49051101A 26464501C 97161201 54123101A 45041401C 18826701 49051101C 49760101A 49051101D 21473201 49051101E 54123101C 54008001C 50024801C 50024801D 97161201A 49760101C 50024801E 21473201A RK8MKE RK9MKE T7DMKE MHLL7Y MHM0DA MHJRE8-R
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution and the country of Canada.
  • Description du dispositif
    Restoration HA Reduced Neck 255 mm Long Stem || Manufactured by Stryker Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430. || The Restoration HA cementless Hip System is designed to address the problems of revision surgery where extensive fixation both distally and proximally is required for support of the prosthesis. A comprehensive size range mates a variety of proximal cross sections and lengths with 10 distal cylindrical diameters to provide for patient matched sizing in revision circumstances. The stem design incorporates a physiologic 127 degree neck stem angle, neck length ranges and a C-Taper head to provide the surgeon with the ability to restore near anatomic head position for proper leg length and biomechanical function. Restoration HA femoral component accepts C-Taper heads, 22mm, 26mm, 28mm, and 32mm with a negative 5mm to positive 10mm offsets.
  • 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