Events

Rappel de Zimmer Persona Tibial Articular Surface Provisional (TASP) Instruments (Supplied as part of the reusable surgical kit used to aid the surgeon in assessing the thickness of articular surface required)

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-2014-RN-01033-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-26
  • 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-2014-RN-01033-1
  • 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
    Zimmer has received complaints related to the fracture of persona tibial articular surface provisional (tasp) tops and bottoms. based on the investigation results of these complaints, zimmer determined that updates to device labelling associated with the zimmer persona knee system were required to provide additional clarifications relating to the instructions for use of the tasp construct. .
  • Action
    Zimmer is advisingthat the updated technique for use of the TASP construct and its components can be found on pp. 34-37 of the Persona Surgical Technique (97-5026-001-00, Rev. 8) which includes: • Apply gentle manual pressure without impacting the TASP construct with either a mallet or hand. The TASP construct includes the TASP top, bottom, shim, and Tibial Sizing Plate Handle. • During assembly of the TASP construct, slide the shim in using a direct anterior approach between the TASP top and bottom. To avoid inadvertent separation, maintain slight pressure between the TASP top and bottom while inserting the shim. • Varus/Valgus forces may make it difficult to remove the TASP construct. To aid in the removal of the TASP and prevent breakage, ensure that the joint is in a neutral position when removing the TASP construct. This action has been closed-out on 18/03/2016.

Device

Zimmer Persona Tibial Articular Surface Provisional (TASP) Instruments (Supplied as part of the r...
  • Modèle / numéro de série
    Zimmer Persona Tibial Articular Surface Provisional (TASP) Instruments (Supplied as part of the reusable surgical kit used to aid the surgeon in assessing the thickness of articular surface required)Multiple part (item) numbersARTG number: 109936
  • 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