Events

Rappel de Biomet Hip 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 Zimmer Biomet, 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
    79685
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1537-2018
  • Date de mise en oeuvre de l'événement
    2018-04-02
  • 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=162993
  • 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, cemented - Product Code JDI
  • Cause
    Two lots of different sized modular heads potentially commingled. risks include delay in surgery and dislocation due to use of an incorrect sized head.
  • Action
    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 4/2/2018 to its customers. The letter described the product, problem and actions to be taken. Distributors will be notified of the recall via email. Hospital risk managers and distributors with product will be notified via courier. The distributor letter includes instructions to locate and remove the product in their territory, identify hospitals who have previously used the product; return on-hand product to the recalling firm and ensure all products are accounted for. The letter for hospital risk managers instruct the risk managers to assist the recalling firm's sales reps with quarantine of the product; to review notification and ensure affected personnel are aware of the contents; and complete and return the Certificate of Acknowledgement form to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have product, and retain a copy. Customers with questions are directed to call customer service at 574-371-3071 between 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Device

Biomet Hip System
  • Modèle / numéro de série
    lot 276760
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.
  • Description du dispositif
    Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis || The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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