Events

Rappel de Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orthopaedic bone screw)

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

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-00979-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-22
  • 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-00979-1
  • 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 was identified that the specified lots of the locking screws stardrive ø 2.4 mm, self-tapping, length 12 mm, tan can break between the head and the shaft. this resulted from the neck feature being too close to the stardrive feature leaving a thin wall between the neck and drive. in the event that the non-conforming screw should separate between the head and the shaft during insertion or removal, a surgical delay may occur as the surgeon attempts to remove the shaft or fragment from the bone. removal of fragments can result in bone damage. additionally, a protruding fragment can lead to adverse tissue reaction or soft tissue irritation.
  • Action
    Johnson &Johnson; Medical (JJM) is advising customers to identify, quarantine and return all unpackaged Locking Screws Stardrive Ø 2.4 mm, self-tapping, length12 mm, TAN in kits along with any screws still in the original packaging with the affected part and lot number. JJM Customer Service will organise replacement products for the returned stock

Device

Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orth...
  • Modèle / numéro de série
    Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orthopaedic bone screw)Part Number: 412.812Lot Numbers: 9744302, 9946065Supplied as part of following systems: LCP Distal Radius System 2.4LCP Compact Hand 2.4LCP Compact Foot 2.42.4/2.7 mm Locking Tarsal PlatesARTG number: 157068
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes