Class II — Novus Scientific Ab
| Recalling firm | Novus Scientific AB |
|---|---|
| Registered facility | NOVUS SCIENTIFIC AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs. |
| Product | TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030 |
| Quantity | 3458 units total (657 units in US) |
| 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 |
| Initiated | 2016-07-19 |
| Classified | 2016-08-19 |
| Terminated | 2016-12-23 |
| Recall number | Z-2603-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Novus Scientific Ab (Z-2603-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74801/
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