Events

Recall of LCP Plate 2.4, straight, 8 holes, length 68 mm, Stainless Steel (fixation plate used to treat orthopaedic fractures)

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-2014-RN-00106-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-01-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00106-1
  • 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 lcp plates from the affected lot were mislabelled with an incorrect lot number. the packaging of these plates were labelled as lot 7709267 whereas the lot etched on the plates is 7709265. synthes australia is recalling all lcp plates labelled as lot 7709265 and lot 7709267.
  • Action
    Synthes is requesting users inspect and return any affected stock to Synthes for replacement.

Device

LCP Plate 2.4, straight, 8 holes, length 68 mm, Stainless Steel (fixation plate used to treat ort...
  • Model / Serial
    LCP Plate 2.4, straight, 8 holes, length 68 mm, Stainless Steel (fixation plate used to treat orthopaedic fractures)Lot numbers: 7709265 and 7709267Part Number: 249.678ARTG Number: 157069
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd