Events

Recall of Retractor for Sciatic Nerve; and Retractor for Sciatic Nerve, long

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-2015-RN-00938-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00938-1
  • 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 & johnson medical pty. ltd. (jjm) is issuing a medical device recall of certain lots of the depuy synthes sciatic nerve retractors, which are found in the 3.5mm low profile pelvic system. please note that there is no replacement for these products available at this time. micropores may form on the hollow handle of the sciatic nerve retractor during the manufacturing process that are large enough to allow fluids to enter and exit the hollow handle.Even with diligent reprocessing/sterilization of the retractor, subsequent patient(s) may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use. in the event that the liquid and/or discoloration is not identified preoperatively and enters the operative theatre, there is the potential for surgical delay while a replacement or alternate retractor is requesteda surgical delay may also occur.
  • Action
    Customers are asked to inspect stock on hand and to quarantine affected units prior to return to JJM for a replacement or an account credit. This action has been closed-out on 05/09/2016.

Device

Retractor for Sciatic Nerve; and Retractor for Sciatic Nerve, long

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes