Events

Recall of Soft Tissue Retractor, small, extendible

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-00420-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00420-1
  • 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
    Synthes have received complaints about tip breakage and/or locking nut malfunction. there have been reports of retrieval of device fragments intraoperatively and delays in surgical procedures.
  • Action
    Customers are requested to return all affect units to DePuy Synthes Australia for replacement units. Synthes will implement a design change to improve the robustness of material of construct of the locking nut.

Device

Soft Tissue Retractor, small, extendible
  • Model / Serial
    Soft Tissue Retractor, small, extendiblePart Number: 325.010All Lot Numbers Affected
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd