Events

Rappel de Lateral Decubitus Alignment Guide

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
    52375
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1817-2009
  • Date de mise en oeuvre de l'événement
    2006-04-27
  • Date de publication de l'événement
    2009-08-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-10-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82807
  • 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
    Impactor - Product Code HWA
  • Cause
    The lateral decubitus alignment guide either did not assemble to its mating part, the curved impaction handle, or partially engages the handle, but does not fully lock.
  • Action
    Important Market Withdrawal Letters were sent to Stryker Branches on April 27, 2006 vis Federal Express. The letter asked consignees to examine their inventory and identify the product. They are to retrieve all affected product lots and return to their branch or agency warehouse for reconciliation. Also, they are to reconcile all product on the attached Product Accountability Form and fax a copy. Affected should be returned and their Stryker Orthopaedics Customer Service Rep should be contacted to re-order the product that is being returned as part of this recall. Questions should be referred to Rita Intorella at 201-831-5825.

Device

Lateral Decubitus Alignment Guide
  • Modèle / numéro de série
    Lot codes: TACFA03, TACFA0G, TACFA0M, TACF12P, & TACG104.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip Acetabular instrument set includes the curved positioner/impactor, supine alignment guide, and decubitus alignment guide. || Catalog No. 1440-1370 || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || Authorized Representative in Europe: Stryker France, Cedex France. || The correct position of the cup relative to the pelvic reference planes can be achieved by the use of the alignment guide.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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