Events

Rappel de Total Temporomandibular Joint Replacement 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 Biomet Microfixation, 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
    69644
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0511-2015
  • Date de mise en oeuvre de l'événement
    2014-10-17
  • Date de publication de l'événement
    2014-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131267
  • 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
    Joint, temporomandibular, implant - Product Code LZD
  • Cause
    Laser etching on the parts is wider and deeper than the conditions previously validated.
  • Action
    BIOMET sent an Urgent Medical Device Recall letter dated October 17, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following steps: 1) Immediately locate and remove from circulation the items invoiced/consigned/loaned to your account. 2) Carefully follow the instructions on the enclosed "Response Form." and 3)If you have further distributed these items to medical facilities, you must notify them of this action. For questions customers were instructed to call 1-800-874-7711 or 904-741-4400, extension 9448, Monday through Friday, 8 a.m. to 4 p.m. EST. For questions regarding this recall call 904-741-9448.

Device

Total Temporomandibular Joint Replacement System
  • Modèle / numéro de série
    Model 01-6545TI, Lot #s: 535380D, 531850A, 531850B, 531860A, 531860B, 535380B, 535380C, 535380A.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
  • Description du dispositif
    Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand || Reconstruction of the temporomandibular joint
  • Manufacturer
    Biomet Microfixation, LLC

Manufacturer

Biomet Microfixation, LLC
  • Adresse du fabricant
    Biomet Microfixation, LLC, 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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