Events

Rappel de Device Recall LOCATOR Implant Attachment System

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 Zest Anchors 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
    67315
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0935-2014
  • Date de mise en oeuvre de l'événement
    2014-01-16
  • Date de publication de l'événement
    2014-02-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125247
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Cause
    Zest anchors, llc is voluntarily recalling specific lots of locator¿ implant attachment systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 n-cm. it was recently noted by zest that in order to provide an optimal performance by increasing the factor of safety between the failure load of the abutment screw and the recommend.
  • Action
    Zest Anchors, LLC initiated this recall by sending customers recall notification letter on 01/16/2014 via FedEx overnight. The customer notification letter, titled, "IMPORTANT: MEDICAL DEVICE VOLUNTARY RECALL NOTICE", informed customers of the recall, reason for voluntary recall, product information with part numbers and lot numbers, actions to be taken, and contact information. The customer notification letter was accompanied by a response form titled "MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement & Receipt Form".

Device

Device Recall LOCATOR Implant Attachment System
  • Modèle / numéro de série
    Part Numbers: 8875-SPI, 8875-SPI-TMS, 8876-SPI, 8876-SPI-TMS, 08877-SPI, 08877-SPI-TMS, 08878-SPI, 08878-SPI-TMS, 08879-SPI, 08880-SPI; Lot Numbers: 11052, 15306, 20665, 21351, 12025,12259, 22440, I0K7X, I0K7Y, 11963,15307,17676,18934, 25294, 25567, I0JQ7, 12258,12941,15000, 19735, 20666, I0K7Z, I0KY7, 12703, 14568, 19832, 22170, I0LCG, 11093, 13364, 14151, 15624, 20043, 25026, 13530, I0LE4, 10055, 14152, 15001, 25027, 10892, 10893.   Since the LOCATOR¿ Implant Attachment System (including the restorative components) is not sold by the Zest Anchors as a sterilized product, it does not have a designated shelf-life.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in Ohio and Switzerland.
  • Description du dispositif
    LOCATOR¿ Implant Attachment System. || The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. || FDA 510(k): K994257, K072878
  • Manufacturer
    Zest Anchors LLC

Manufacturer

Zest Anchors LLC
  • Adresse du fabricant
    Zest Anchors LLC, 2061 Wineridge Pl, Escondido CA 92029-1947
  • Source
    USFDA