Events

Rappel de Device Recall Abutment Retrieval Instrument

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 Nobel Biocare Usa Llc.

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
    71552
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2074-2015
  • Date de mise en oeuvre de l'événement
    2015-06-22
  • Date de publication de l'événement
    2015-07-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138182
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • Cause
    One dimension of the affected instrument is incorrect. therefore this instrument cannot be used to remove the metal adapter as intended.
  • Action
    A customer notification letter dated 6/22/15 will be sent to all customers who purchased the Abutment Retrieval Instrument Zirconia CC RP/WP because an internal investigation showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended. The letter provides the problems identified and the actions to be taken. Customers are instructed to complete the acknowledgement form and return it to their local Nobel Biocare Subsidiary with the affected instrument. Customers with the affected instrument that is a part of a kit, Nobel Biocare Representative will contact them directly. Customers with any remaining questions, are instructed to contact their Nobel Biocare Representative.

Device

Device Recall Abutment Retrieval Instrument
  • Modèle / numéro de série
    Article No. 37882, Batch No. 96149; Article No. 37508, Batch No. 814929, 815096, 815140, and 855021.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
  • Description du dispositif
    Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.
  • Manufacturer
    Nobel Biocare Usa Llc

Manufacturer

Nobel Biocare Usa Llc
  • Adresse du fabricant
    Nobel Biocare Usa Llc, 22715/22725 Savi Ranch Pkwy, Yorba Linda CA 92887
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA