Events

Rappel de A.L.P.S. 4.0mm Cancellous Locking Screws (non-sterile)CNCLS LOCK SCREW FT4.0x10mm, 4.0x12mm, 4.0x14mm, 4.0x16mm, 4.0x18mm, 4.0x20mm, 4.0x22mm ,4.0x24mm, 4.0x26mm, 4.0x28mm, 4.0x30mm, 4.0x32mm, 4.0x34mm, 4.0x36mm, 4.0x38mm, 4.0x40mm, 4.0x42mm, 4.0x44mm, 4.0x46mm, 4.0x48mm, 4.0x50mm, 4.0x55mm, 4.0x60mm, 4.0x65mm, 4.0x70mm, 4.0x75mm, 4.0x80mm, 4.0x85mm, 4.0x90mm, 4.0x95mm, 4.0x100mm

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomet Australia 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-01162-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-30
  • 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-01162-1
  • 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
    It has been identified that all lots of a.L.P.S. 4.0mm cancellous locking screws, manufactured between june 1, 2008 and june 4, 2015, have a single lead thread instead of a triple lead thread. a single lead screw may sit proud in the plate which could lead to soft tissue irritation. in addition, if the screw does not lock into the plate, it is possible for the screw to back out. in the event that the screw does not lock into the plate and backs out, a revision surgery may be necessary.
  • Action
    Zimmer Biomet is advising users to inspect stock and quarantine the affected unused units prior to their return to the sponsor. The sponsor will replace the affected unused units. Patients who have been implanted with the affected units should be monitored by qualified healthcare professional. For more details, please see https://www.tga.gov.au/alert/anatomic-locked-plating-system-4-mm-cancellous-locking-screws-used-treat-broken-bones . This action has been closed-out on 29/08/2016.

Device

A.L.P.S. 4.0mm Cancellous Locking Screws (non-sterile)CNCLS LOCK SCREW FT4.0x10mm, 4.0x12mm, 4.0x...
  • Modèle / numéro de série
    A.L.P.S. 4.0mm Cancellous Locking Screws (non-sterile)CNCLS LOCK SCREW FT4.0x10mm, 4.0x12mm, 4.0x14mm, 4.0x16mm, 4.0x18mm, 4.0x20mm, 4.0x22mm ,4.0x24mm, 4.0x26mm, 4.0x28mm, 4.0x30mm, 4.0x32mm, 4.0x34mm, 4.0x36mm, 4.0x38mm, 4.0x40mm, 4.0x42mm, 4.0x44mm, 4.0x46mm, 4.0x48mm, 4.0x50mm, 4.0x55mm, 4.0x60mm, 4.0x65mm, 4.0x70mm, 4.0x75mm, 4.0x80mm, 4.0x85mm, 4.0x90mm, 4.0x95mm, 4.0x100mmMultiple Part Numbers AffectedAll Lot Numbers AffectedARTG Number: 209305
  • Manufacturer
    Biomet Australia Pty Ltd

Manufacturer

Biomet Australia 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