Events

Recall of SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2015-RN-00574-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00574-1
  • 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
    Stryker has been made aware of a spike in the occurrence of tip breaks identified for the 90r probe. the investigation triggered by same confirmed the shape and location of the tip break in each case to be the same. in each event a small piece from the distal end of the alumina ceramic broke off. the geometry of this type of crack differs from those normally observed by serfas probes.
  • Action
    Customers are asked to check any SERFAS 90° Energy Probe items in their possession and quarantine any affected units immediately . A Stryker Representative will coordinate an inspection of your affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued. This action has been closed-out on 08/08/2016.

Device

SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)
  • Model / Serial
    SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)Item Number: 279-350-101Affected Lots: 13128AE2 to 14337AE2ARTG Number: 146512
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA