Events

Rappel de Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.

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 Highland Metals, Inc..

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
    67378
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0922-2014
  • Date de mise en oeuvre de l'événement
    2013-12-13
  • Date de publication de l'événement
    2014-02-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125369
  • 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
    Wire, orthodontic - Product Code DZC
  • Cause
    Labeling issue: product labeled as "upper" may contain "lower" archwires with a red midline mark. product labeled ad "lower" may contain "upper" archwires with a black midline mark.
  • Action
    Highland Metals sent an Urgent Field Safety Notice with a response form to all affected consignees on December 13, 2013, via email.. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to pass the Field Safety Notice to all those who needed to be aware within their organization or to any organization where the potentially affected devices have been transferred. Consignees were instructed to complete the Acknowledgement of Receipt and Action form and fax to 1-408-271-2962 or email to quality@highlandmetals.com. For questions regarding this recall call 408-271-2955.

Device

Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.
  • Modèle / numéro de série
    Part Number Part Description Lot Number Label Form Actual Form 11100161124 SE Niti 016 Nat U 100 41684 Upper Lower 11100161125 SE Niti 016 Nat U 10 41684 Upper Lower 11100161144 SE Niti 016 Nat L 100 41679 Lower Upper
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
  • Description du dispositif
    SuperElastic Regular force NiTi lower or upper Natural arches. || 0.16 size || 10 or 100 count packages. || Highland Metals Inc. || San Jose, CA || The devices are intended to provide force to the teeth to effect movement in order to alter their position.
  • Manufacturer
    Highland Metals, Inc.

Manufacturer

Highland Metals, Inc.
  • Adresse du fabricant
    Highland Metals, Inc., 419 Perrymont Ave, San Jose CA 95125-1445
  • Source
    USFDA