Events

Recall of DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Regeneration Matrix (Dura mater grafts indicated for the repair or primary closure of dura (brain and spinal chord) for regeneration)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences 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-2013-RN-00352-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00352-1
  • 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
    The production process may have deviated during the manufacture of specific lots.The product lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products.
  • Action
    Integra is recalling the affected product and is asking clinicans to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol.

Device

DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Rege...
  • Model / Serial
    DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Regeneration Matrix (Dura mater grafts indicated for the repair or primary closure of dura (brain and spinal chord) for regeneration)Catalogue Numbers: ID-1101-(I), ID-1105-(I), ID-1301-(I), ID-1305-(I), ID-2201-(I), ID-2205-I, ID-3305-(I), ID-4501-(I), DP-1013-I, DP-1022-I, DP-1033-I, DP-1045-I, DP-1057-I, DURS2291, DURS3391, DURS4591Multiple lots affectedARTG: 158829, 158825 & 158826
  • Product Classification
    Neurological Devices
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd