Events

Rappel de Device Recall Navitrack System OS Knee Universal

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 Orthosoft, Inc. dba 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
    75612
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2075-2017
  • Date de mise en oeuvre de l'événement
    2008-06-20
  • Date de publication de l'événement
    2017-05-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154948
  • 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
    Neurological stereotaxic Instrument - Product Code HAW
  • Cause
    Zimmer cas voluntarily conducted a retrospective recall of the navitrack system - os knee universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
  • Action
    This is a retrospective report of a correction taken on 20 June 2008. The two software issues were corrected in the new software version 2.2.1.3. There were 164 copies of the affected software, 5 of which were only temporary licenses. There were 152 of the 159 software copies that had a full license that were confirmed to have installed the updated instructions per the correction notice for a total percentage of 96%. All sales representatives were made aware of the software issues by written notice. Both software issues were corrected in a new revision of the software with no remaining effect. There have been no complaints since the correction was implemented. Recall notices were e-mailed to customers dated 06/20/2008.

Device

Device Recall Navitrack System OS Knee Universal
  • Modèle / numéro de série
    Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Domestic: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI Foreign: Germany, Spain, Czech Republic, Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, United Kingdom
  • Description du dispositif
    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
  • Manufacturer
    Orthosoft, Inc. dba Zimmer CAS

Manufacturer

Orthosoft, Inc. dba Zimmer CAS
  • Adresse du fabricant
    Orthosoft, Inc. dba 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