Events

Recall of MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain System

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-2017-RN-00052-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00052-1
  • 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
    A report has been received indicating that the outer label of a medpor sizer set states ‘sterile’, whereas the product is actually delivered non-sterile. investigations have revealed that additional products and lots have an incorrect sterility status on their labels. the introduction of a non-sterile device into the sterile surgery field could potentially cause infection requiring additional medical or surgical treatment.
  • Action
    Stryker is advising users to inspect their inventory and quarantine affected stock. They are requested to contact Stryker to coordinate the return of affected products for a resupply or a credit. This action has been closed out on 16 June 2017.

Device

MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain System
  • Model / Serial
    MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain SystemItem Numbers: 6630, 9951, 9952Multiple Lot NumbersARTG Numbers: 258033, 264273
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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