Events

Rappel de Device Recall Avenir Muller Stem

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 GmbH.

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
    79677
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1525-2018
  • Date de mise en oeuvre de l'événement
    2018-02-28
  • 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=162957
  • 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/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Cause
    A potential commingle that could result in the product in the package not matching the product on the outer label.
  • Action
    On March 7, 2018 Field Safety Corrective Action Notices were hand delivered by Zimmer Biomet team members or their representatives. Customers were instructed to complete the following: 1.Review this notification for awareness of the contents. 2.Assist your Zimmer Biomet sales representative to quarantine immediately all affected implants. 3.Your Zimmer Biomet sales representative will remove the affected implants from your facility. 4.Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to fieldaction.emea@zimmerbiomet.com. b. Retain a copy of the Certificate of Acknowledgement with your field action records in the event of a compliance audit of your documentation. 5.If after reviewing the notice you have further questions or concerns please contact your Zimmer Biomet representative.

Device

Device Recall Avenir Muller Stem
  • Modèle / numéro de série
    Lot Number: 2905496
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.
  • Description du dispositif
    Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
  • Manufacturer
    Zimmer GmbH

Manufacturer

Zimmer GmbH
  • Adresse du fabricant
    Zimmer GmbH, Sulzerallee 8, Winterthur Switzerland
  • 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