Events

Rappel de Device Recall GoDirect

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 Implant Direct Sybron Manufacturing, 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
    73448
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1267-2016
  • Date de mise en oeuvre de l'événement
    2016-03-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144215
  • 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
    Implant direct sybron manufacturing, llc is recalling godirect implants because some consignees did not receive the correct tool to drive the implant to bone level.
  • Action
    Implant Direct sent an Urgent: Medical Device Field Corrective Action letter dated March 4, 2016, to all affected customers. The letter states that Implant Direct will correct the issue and send the proper tool. The proper tool is included with the notification. The letter requests that customers complete and return the Acknowledgement and Recall Return Form within 48 hours. It customers are an authorized Implant Direct Sybron Manufacturing distributor it is requested that customers are identified and contact them to inform them of the issue within 48 hours of receiving the notification. Distributors should also provide customers with the correct tool. If you have any of the affected product listed above and have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. For further questions regarding this please call (818) 444-3300 Ext. 3323

Device

Device Recall GoDirect
  • Modèle / numéro de série
    Lot Number: 29707, 29708, 29709, 32444, 37438, 38159, 39506, 40394, 40542, 44661, 46030, 50644, 50824, 51092, 51249, 52798, 54274, 54275, 54617, 55407,60158
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - Nationwide Distribution to the states of : FL, AZ, IL, MS, TX, CA, ID, AL, MO, MN, NY, CO, GA, ME, NJ, NC, NV, LA, KS, MN, KY, PA, UT, OH, MI, SC, MD, WA, WI., and to the countries of : Canada, Honduras and Dominican Republic.
  • Description du dispositif
    The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. || GoDirect Implants || Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710
  • Manufacturer
    Implant Direct Sybron Manufacturing, LLC

Manufacturer

Implant Direct Sybron Manufacturing, LLC
  • Adresse du fabricant
    Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Westlake Village CA 91362-3171
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA