Recall of Integra Suturable Duragen

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Integra LifeSciences Corporation.

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
  • Event ID
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Integra Neurosciences Pty Ltd (NZ), 5B Suite B, 331 Rosedale Road, Albany, Auckland 0632
  • Reason
    Specific lots of some collagen products may have deviated from a production process. the affected lots passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to a process deviation, they may have been released with higher levels of endotoxins that permitted by release specifications. higher endotoxin levels may result in fever in the immediate postoperative period. the manufacturer are not aware of any reports of patient injuries or other adverse events in connection with these product lots., the health hazard evaluation (hhe) provided by the manufacturer details that during an internal quality assurance review of processes, specific lots manufactured during the periods december 2010 to may 2011, and then december 2012 to february 2013, may possibly be affected.
  • Action
    Product to be returned to supplier