FDA-Device2016-08-31Class II
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Novus Scientific Ab
Hazard
Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
Sold states
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
Affected count
3458 units total (657 units in US)
Manufactured in
Virdings Alle 2, Uppsala, Sweden
Products
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2603-2016Don't want to check this manually?
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