Events

Recall of 2.7mm Self-Tapping Cortex Screw (internal fixation device)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Advanced Surgical Design & Manufacture Limited.

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-2012-RN-01186-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01186-1
  • 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
    Advanced surgical design & manufacture ltd, following a report of a fracture of the screw head during surgery, has determined that the affected products may be out of specification.
  • Action
    Advanced Surgical Design and Manufacture is asking customers to quarantine and return all affected devices for replacement stock.

Device

2.7mm Self-Tapping Cortex Screw (internal fixation device)
  • Model / Serial
    2.7mm Self-Tapping Cortex Screw (internal fixation device)ASDM Part Numbers: 351-012, 351-014 & 341-016Lot Numbers: 11164100, 11164200, 11164900 & 11165100ARTG Number: 134456
  • Manufacturer
    Advanced Surgical Design & Manufacture Limited

Manufacturer

Advanced Surgical Design & Manufacture Limited