Events

Recall of Sciatic Nerve Retractors

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-2018-RN-00334-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00334-1
  • 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
    Johnson and johnson has identified the potential for micropores to form on the hollow handle of the sciatic nerve retractor. the pores may increase in size, allowing fluid to enter the hollow handle. discoloration and moisture were identified within the packaging of the affected lots of sciatic nerve retractors indicating that these pores may be present in the affected devices.Even with diligent reprocessing/sterilisation of the retractor, subsequent patients may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use.
  • Action
    Johnson and Johnson are advising users to inspect stock and return any affected product as soon as possible.

Device

Sciatic Nerve Retractors
  • Model / Serial
    Sciatic Nerve Retractors Part Numbers: 03.100.013, 03.100.014Lot Numbers: T140390, T140675, T140677 ,T145819, T140566, T140673, T151369ARTG Number: 296161Johnson & Johnson Medical t/a DePuy Synthes - Wound retractor, intermediate/deep
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes