Events

Recall of MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.)

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-2014-RN-01367-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01367-1
  • 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 become aware that there is a higher occurrence rate of implant damaged during intra-operative handling for the part number noted above. additionally, a loss of adhesion between the barrier sheet and the porous sheet may be also experienced during intra-operative handling and modification. post-operative harm is unlikely to be associated or identified with the use of the affected device.
  • Action
    Stryker is informing all the MEDPOR barrier users of the issue and recalling the device. A Stryker Representative will contact the customer to arrange for product return and replacement. This action has been closed-out on 18/07/2016.

Device

MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or re...
  • Model / Serial
    MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.)Catalogue Number: 9305Lot Numbers: A1312011, 77004 & 81799ARTG Number: 187178
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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