Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00979-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00979-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
    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