Events

Rappel de Zimmer Natural Nail CM Long- Cephalomedullary Nails

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
    Recall
  • ID de l'événement
    RC-2015-RN-01000-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01000-1
  • 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
    The cephalomedullary nails are packaged in double sterile barrier packaging that includes the placement of the product in a protective pouch and then into two sterile barrier trays (inner and outer). in approximately 5% of the tested samples, the outer tray was found to be compromised, however, there were no records which suggested that the sterility of the inner tray was affected. to date no complaints have been received regarding compromised packaging.
  • Action
    Zimmer is advising users to inspect current stock for damaged packaging and quarantine any affected units. Damaged product can be returned to Zimmer for replacement. This action has been closed-out on 22/08/2016.

Device

Zimmer Natural Nail CM Long- Cephalomedullary Nails
  • Modèle / numéro de série
    Zimmer Natural Nail CM Long- Cephalomedullary NailsAll product manufactured and packaged between July 2009 to July 2015Multiple product codes and lot numbers affectedARTG Number: 169894
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • 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
    DHTGA