Events

Rappel de Legacy(TM) 3 Implant

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
    78350
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0185-2018
  • Date de mise en oeuvre de l'événement
    2017-10-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159290
  • 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
    One reported complaint and discovered that the outer vial was out of round and undersized. therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. as a result, the cap could possibly not be screwed on properly and the sterilization compromised.
  • Action
    The firm, Implant Direct Sybron Manufacturing, LLC, sent an "URGENT: Safety Alert/Advisory Notice" letter to its distributors/customers on 10/10/2017. Distributors were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with replacement product." Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customers were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. Please share this information with your staff and retain this notification as part of your documentation. Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425."

Device

Legacy(TM) 3 Implant
  • Modèle / numéro de série
    Lot Number: 79607
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.
  • Description du dispositif
    ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 || This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
  • 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