Rappel de Zimmer Periarticular Femoral Cond Buttress Plate and Zimmer Periarticular Distal Lateral Femoral Locking Plate

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Zimmer Pty Ltd.

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Zimmer recently conducted a review of historic packaging validations. based on this review, it was determined that a subset of product packaged at a zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. this testing determined that a packaging tray configuration, consisting of an inner and outer sterile tray, resulted in cosmetic failures related to the visual quality of the seal (homogeneous adhesive transfer). this failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. no physical failures in either peel strength or pressure testing were observed.
  • Action
    Hospitals are requested to quarantine all affected product in their inventory. Return of affected product can be organised through a Zimmer Sales Representative.


  • Modèle / numéro de série
    Zimmer Periarticular Femoral Cond Buttress Plate and Zimmer Periarticular Distal Lateral Femoral Locking PlateAll Lots with an expiration date prior to July 24, 2023FEM COND BUTTRESS PLT, RT: 00-2347-001-12, 14, 16, 18FEM COND BUTTRESS PLT, LT: 00-2347-002-12, 14, 16, 18DIST LAT FEM LOCK PLT, RT: 47-2357-101-14, 18DIST LAT FEM LOCK PLT, LT: 47-2357-102-14, 18
  • Manufacturer


  • Société-mère du fabricant (2017)
  • 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