Events

Rappel de TRINICA ANTERIOR LUMBAR PLATE (ALP) SYSTEM CASE ASSEMBLY

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
    132676
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-10
  • 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 device correction for the trinica anterior lumbar plate (alp) system case assembly. the ratchet handles part number 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. this is due to the current bracketing in the tray which may interfere with complete steam penetration into the cannulated handle. to assure effective sterilization the ratchet handles must be sterilized external to the instrument tray until newly designed replacement trays are available.

Device

TRINICA ANTERIOR LUMBAR PLATE (ALP) SYSTEM CASE ASSEMBLY
  • Modèle / numéro de série
    Model Catalog: 07.01058.001 (Lot serial: P061255)
  • Description du dispositif
    TRINICA ALP SYSTEM CASE ASSEMBLY
  • 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