Events

Rappel de TRABECULAR METAL PRIMARY HIP PROSTHESIS-FEMORAL STEM EXTENDED NECK OFFSET

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
    28403
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2018-01-03
  • 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 biomet is conducting a medical device recall for two lots of trabecular metal stems noted in the table above. a complaint was received indicating that a "13mm extended" stem was in a box labelled as a "13mm standard" stem. the investigation determined that the lots were commingled hence both the lots are being recalled from the field.

Device

TRABECULAR METAL PRIMARY HIP PROSTHESIS-FEMORAL STEM EXTENDED NECK OFFSET
  • Modèle / numéro de série
    Model Catalog: 00-7864-013-20 (Lot serial: 63703681); Model Catalog: 00-7864-013-00 (Lot serial: 63703649)
  • Description du dispositif
    TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM SIZE 13 138 MM STEM LENGTH EXTENDED OFFSET;TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM SIZE 13 138 MM STEM LENGTH STANDARD OFFSET
  • 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