Events

Rappel de Tibial Alignment Guide

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 CAS.

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
    71202
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1701-2015
  • Date de mise en oeuvre de l'événement
    2015-04-19
  • Date de publication de l'événement
    2015-06-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137123
  • 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
    Orthopedic stereotaxic instrument - Product Code OLO
  • Cause
    Zimmer cas has determined that the potential exists for the spikes on the iassist tibial alignment guide to bend or break during insertion or extraction from the tibia during use.
  • Action
    Zimmer distributed notices via certified mail on May 14, 2015. Zimmer is removing affected Tibial Alignment Guide iAssist Knee System product from distribution in a two-phased process. Based upon complaint investigation, Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. Customerswere asked to review the notifictaion, follow the iASSIST Surgical Knee Technique provided, further distribute the notice for any distributed product, inspect devices in use before and after procedures, report any adverse events, and complete the certificate of acknowledgment and return it to CorporateQuality.PostMarket@zimmer.com. Customers with questions concerning this notice, please contact Customer Service at the following address/phone number. Customer Service / Zimmer CAS 75 Queen Street, Suite 3300 Montreal, Quebec, Canada H3C 2N6 Email : cas-support@zimmercas.com, Telephone : 1-514-395-8883, toll free for North America 1-866-336-7846, Fax : 1-866-978-3801. For questions regarding this recall 574-372-4487.

Device

Tibial Alignment Guide
  • Modèle / numéro de série
    Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.
  • Description du dispositif
    Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
  • Manufacturer
    Zimmer CAS

Manufacturer

Zimmer CAS
  • Adresse du fabricant
    Zimmer CAS, 75 Queen St #3300, Montreal Canada
  • 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