Medical device recalls Moderate risk

Novus Scientific Ab recalls TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030

Recall date
July 19, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2603-2016
FDA classification
Class II
Brand / firm
Novus Scientific Ab
Sold / distributed
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

Why it was recalled

Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030

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