Events

Rappel de Trilogy cups and screws

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, 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
    66500
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1024-2014
  • Date de mise en oeuvre de l'événement
    2013-10-11
  • Date de publication de l'événement
    2014-02-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124870
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Cause
    Zimmer recently conducted a review of all historic packaging validations at its zimmer manufacturing b.V. (zmbv) facility in ponce, puerto rico. based on this review, it was determined that the packaging operations conducted in the building 1 packaging operation at this facility were not properly validated. as a result, zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. the acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. these packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the zmbv facility building 1 packaging operations.
  • Action
    Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.

Device

Trilogy cups and screws
  • Modèle / numéro de série
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
  • Description du dispositif
    TRILOGY ACET SHELL 36MM O || TRILOGY ACET SHELL 38MM O || TRILOGY ACET SHELL 40MM O || TRILOGY ACET SHELL 42MM O || TRILOGY ACET SHELL 44MM O || TRILOGY ACET SHELL 46MM O || TRILOGY ACET SHELL 48MM O || TRILOGY ACET SHELL 50MM O || TRILOGY ACET SHELL 52MM O || TRILOGY ACET SHELL 54MM O || TRILOGY ACET SHELL 56MM O || TRILOGY ACET SHELL 58MM O || TRILOGY ACET SHELL 60MM O || TRILOGY ACET SHELL 62MM O || TRILOGY ACET SHELL 64MM O || TRILOGY ACET SHELL 66MM O || TRILOGY ACET SHELL 68MM O || TRILOGY ACET SHELL 70MM O || TRILOGY ACET SHELL 72MM O || TRILOGY ACET SHELL 74MM O || TRILOGY ACET SHELL 76MM O || TRILOGY ACET SHELL 78MM O || TRILOGY ACET SHELL 80MM O || BONE SCREW 4.5X15 SELF-TA || BONE SCREW 4.5X20 SELF-TA || BONE SCREW 4.5X25 SELF-TA || BONE SCREW 4.5X30 SELF-TA || BONE SCREW 4.5X35 SELF-TA || BONE SCREW 4.5X40 SELF-TA || BONE SCREW 4.5X50 SELF-TA || BONE SCREW 4.5X60 SELF-TA || BONE SCREW 6.5X15 SELF-TA || BONE SCREW 6.5X20 SELF-TA || BONE SCREW 6.5X25 SELF-TA || BONE SCREW 6.5X30 SELF-TA || BONE SCREW 6.5X35 SELF-TA || BONE SCREW 6.5X40 SELF-TA || BONE SCREW 6.5X50 SELF-TA || BONE SCREW 6.5X60 SELF-TA || BONE SCREW 6.5X70 SELF-TA || BONE SCREW 6.5X80 SELF-TA
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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