Events

Recall of Nitinol Staples Elastic Staples - Large and Small Symmetrical

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by LMT Surgical 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-2018-RN-00354-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00354-1
  • 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
    During a retrospective review of sterilisation records, trimed has determined that evidence of quarterly dose audits/verification required to comply with the relevant regulations could not be found. sterilization records indicate that all lots of staples were irradiated to at least the defined dose and although trimed has not received any reports of adverse events or injuries, there is a risk that this issue could result in patient infection if not properly sterilised.
  • Action
    As a permanent corrective action, TriMed will recall all of the Nitinol Staples that were manufactured between March 12, 2015 to the present date.

Device

Nitinol Staples Elastic Staples - Large and Small Symmetrical
  • Model / Serial
    Nitinol StaplesElastic Staples - Large and Small SymmetricalMultiple Model and Lot NumbersPanel Code: 87 Orthopedic, Part 888.3030Product Code: JDRAll staples manufactured between March 12, 2015 - presentARTG Number: 229705LMT Surgical - Fixation device, internal, staple
  • Manufacturer
    LMT Surgical Pty Ltd

Manufacturer

LMT Surgical Pty Ltd