Events

Recall of LCP Distal Tibial Plates 3.5 anterolateral, left, 9 holes, length 132mm Stainless Steel Sterile

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-00102-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00102-1
  • 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 has been discovered that the outer packaging and the inner pouch of affected part and lot numbers may not be sealed; thus the implant are potentially not sterile. infection and adverse tissue reaction may occur if the plate is implanted despite unsealed peel pouches.
  • Action
    Johnson & Johnson Medical (JJM) is advising users to inspect stock and quarantine any affected units. Affected stock can be returned to JJM.

Device

LCP Distal Tibial Plates 3.5 anterolateral, left, 9 holes, length 132mm Stainless Steel Sterile

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes