Events

Recall of Device Recall TIGR Matrix Surgical Mesh

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Novus Scientific Ab.

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
    74801
  • Event Risk Class
    Class 2
  • Event Number
    Z-2603-2016
  • Event Initiated Date
    2016-07-19
  • Event Date Posted
    2016-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148479
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mesh, surgical, polymeric - Product Code FTL
  • Reason
    Novus scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
  • Action
    An Urgent Safety Alert letter dated 7/19/16 was sent to all their customers to inform them that Novus Scientific is implementing additions to the product's instructions for use (IFU) with a new contraindication and warning related to the clinical study result. The letter informs the customers that until the new IFU is made available, surgeons using the product for hernia repair should follow the instructions in the urgent safety alert in addition to those in the current IFU. Customers are informed of the actions to be taken: " Additional contraindication: Not suitable for the repair of direct inguinal hernias. " Additional warning: Because TIGR Matrix Surgical Mesh is fully resorbable, it should not be used in repairs where permanent support from the mesh is required. Customers with any questions or concerns are instructed to contact Novus Scientific AB ( +46 (0)18 700 11 50.

Device

Device Recall TIGR Matrix Surgical Mesh
  • Model / Serial
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US : IL, CA, FL, KY, MO, NH, VA, TX, NC, OH, NY, TN, Worldwide: Sweden, Italy, Denmark, UK, Singapore, Germany, Belgium, Spain, Austria, Israel, Malta, Switzerland, Ireland, Norway, Netherlands, Turkey, New Zealand, Bulgaria, France, Iran, Finland, Poland, South Africa
  • Product Description
    TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
  • Manufacturer
    Novus Scientific Ab

Manufacturer

Novus Scientific Ab
  • Manufacturer Address
    Novus Scientific Ab, Virdings Alle 2, Uppsala Sweden
  • Manufacturer Parent Company (2017)
    Novus Scientific Ab
  • Source
    USFDA