Events

Rappel de Device Recall Straumann

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 Straumann 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
    62575
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2161-2012
  • Date de mise en oeuvre de l'événement
    2012-07-11
  • Date de publication de l'événement
    2012-08-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111078
  • 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
    Abutment, implant, dental, endosseous - Product Code NHA
  • Cause
    Incorrect screw (rc) included with nc cares abutment set was not a narrow crossfit (nc) screw for cares nc abutment zro2.
  • Action
    Straumann notiifed accounts by telephone on July 10, 2012 and follow-up Field Safety Correction Action letter dated July 11, 2012, via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to discontinue use of the affected product and follow the instruction provided until replacement is received. For questions call 978-747-2514.

Device

Device Recall Straumann
  • Modèle / numéro de série
    26217US_10008_00_b00; 25262US_10115_00_b05; 25262US_10115_00_b06; 21408US_10073_00_b01; 26199US _10021_00_b00; 25143US_ 10215_00_ b01; 25267US_10278- 00_ b01; 25267US _10280_ 00_b01; 25267US_ 1280_ 00_b03;  25310US_10342_03_b01; 25310US_10342_03_b03; 25310US_10342_03_b05; 25310US_10345_00_b01; 26249US_10019_00_b01;
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution including the countries of FL, IN, LA, NY and TX.
  • Description du dispositif
    Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant || Article Number: 027.2650 || Product Usage: || Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
  • Manufacturer
    Straumann USA, LLC

Manufacturer

Straumann USA, LLC
  • Adresse du fabricant
    Straumann USA, LLC, 60 Minuteman Rd, Andover MA 01810-1008
  • Société-mère du fabricant (2017)
    Straumann Holding AG
  • Source
    USFDA