Events

Rappel de COMPREHENSIVE SEGMENTAL REVISION SYSTEM - DISTAL BODY WITH SCREW

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
    37147
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2018-03-08
  • 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 recall of specific lots of the comprehensive segmental revision system (srs)/discovery distal body with screw. zimmer biomet has received reports that during assembly an srs humeral distal body implant failed to engage correctly at the point of reduction with a discovery elbow system humeral condyle. a mismatch occurred between the screw holes in the distal humeral body and the discovery elbow condyle implant during vendor machine operation. the mismatch does not always prevent engagement of the screw and the condition would be noticed during assembly.

Device

COMPREHENSIVE SEGMENTAL REVISION SYSTEM - DISTAL BODY WITH SCREW
  • Modèle / numéro de série
    Model Catalog: 211253 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 211252 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 211251 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 211250 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 211255 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 211254 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Description du dispositif
    COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)/DISCOVERY DISTAL BODY WITH SCREW 50MM-70MM
  • 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