Events

Rappel de Self Tapping Bone Screws, 6.5 x 20 and 6.5 x 25

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-2016-RN-00678-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-25
  • 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-2016-RN-00678-1
  • 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 inc. has become aware of specific lots of sterile hip and trauma implant screws manufactured between february 2016 and march 2016. these screws are packaged with a double barrier system, two plastic trays and two tyvek lids, to provide sterile integrity. process monitoring conducted as part of the standard packaging process identified that in some instances, a small hole may be present in the inner tray, which were found to be caused by a single tool used by the tray supplier in the manufacturing process and estimated to be present in less than 10% of the affected devices. the outer tray is not affected and the device’s sterile integrity remains until the outer tray is opened.
  • Action
    Zimmer is advising surgeons to review the notification and ensure affected personnel are aware of the contents. Patient follow up is at the discretion of the treating surgeon. This action has been closed-out on 27/01/2017.

Device

Self Tapping Bone Screws, 6.5 x 20 and 6.5 x 25
  • Modèle / numéro de série
    Self Tapping Bone Screws, 6.5 x 20 and 6.5 x 25Self Tapping Bone Screw 6.5 x 20Part Number: 00-6250-065-20Lot Number: 63301504Self Tapping Bone Screw, 6.5 x 25Part Number: 00-6624-065-25Lot Number: 63276975ARTG Number: 169898
  • 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