Events

Recall of LCP Distal Femoral Plate 4.5/5.0, right, 19 holes, length 436 mm, Titanium Alloy (TAN), sterile (Orthopaedic fixation plate)

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

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-2013-RN-00366-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00366-1
  • 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
    The product description on the six languages label on the back of the box is incorrect in spanish and portuguese. instead of right, the plate is described as being a left plate in these two languages.
  • Action
    Synthes is recalling the affected product from the market.

Device

LCP Distal Femoral Plate 4.5/5.0, right, 19 holes, length 436 mm, Titanium Alloy (TAN), sterile (...
  • Model / Serial
    LCP Distal Femoral Plate 4.5/5.0, right, 19 holes, length 436 mm, Titanium Alloy (TAN), sterile (Orthopaedic fixation plate)Part Number: 04.124.038S Lot Numbers: 3415605, 3443957, 3445554, 3490362, 3490393, 3501330, 3562221, 3585780, 3614924, 3618891, 3618892, 3809489, 3824272, 7557106, 7557107, 7564443, 7564444, 7565993, 7565995, 7574198, 7574199, 7587722, 8174821, 8191379, 8239937, 8300566ARTG Number: 157069
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd