Events

Rappel de TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION GLENOSPHERE DISTRACTOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ZIMMER BIOMET CANADA 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
    107771
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-08-06
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Zimmer is initiating a lot specific recall of the trabecular metal reverse shoulder system instrumentation glenosphere distractor due to the potential for the device to not function properly if used without proper lubrication. as a result the device could fail to provide impact to the glenosphere when the trigger is pulled. in addition the foot of the device may fracture during use which could result in the device being unable to remove the glenosphere.

Device

TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION GLENOSPHERE DISTRACTOR
  • Modèle / numéro de série
    Model Catalog: 00-4309-049-00 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Description du dispositif
    TRABECULAR REVERSE GLENOSPHERE DISTRACT
  • Manufacturer
    ZIMMER BIOMET CANADA INC.

Manufacturer

ZIMMER BIOMET CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • 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
    HC