Events

Rappel de Device Recall Endosseous Dental Implant Accessories

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 Zimmer Dental Inc.

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
    77911
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3207-2017
  • Date de mise en oeuvre de l'événement
    2017-07-10
  • 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=158315
  • 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
    Zimmer biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard ifus. all the products were missing supplemental ifus.
  • Action
    The affected customers are being provided instructions on how to obtain the supplemental IFUs for respective part numbers from appropriate E-labeling website along with a recall notice.

Device

Device Recall Endosseous Dental Implant Accessories
  • Modèle / numéro de série
    lot # 63145351, 63202941, 60646055, 62353334, 63316134
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
  • Description du dispositif
    TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; || TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; || TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; || TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
  • Manufacturer
    Zimmer Dental Inc

Manufacturer

Zimmer Dental Inc
  • Adresse du fabricant
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA