Events

Rappel de Device Recall Trinica

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 Spine, 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
    29908
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0040-05
  • Date de mise en oeuvre de l'événement
    2004-08-24
  • Date de publication de l'événement
    2004-10-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-11-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34756
  • 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
    Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
  • Cause
    To date, there has been one complaint reported. during a trinica surgical case, the surgeon was provided a standard disposable, trinica drill bit (part number 07.00166.001) for use with the trinica all through one drill guide instrumentation, instead of the all through one drill bit. this enabled the physician to drill a few millimeters further than expected.
  • Action
    The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.

Device

Device Recall Trinica
  • Modèle / numéro de série
    Serial Numbers: ATO-001 through ATO-0082
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Product was distributed nationwide throughout the United States. Product was not distributed outside of the United States.
  • Description du dispositif
    ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
  • Manufacturer
    Zimmer Spine, Inc.

Manufacturer

Zimmer Spine, Inc.
  • Adresse du fabricant
    Zimmer Spine, Inc., 7375 Bush Lake Rd, Minneapolis MN 55439-2027
  • 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