Novus Scientific Recalls TIGR Matrix Surgical Mesh for Labeling Updates
Novus Scientific is updating instructions for use for TIGR Matrix Surgical Mesh regarding inguinal hernia repairs.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the action is for adding to instructions for use (labeling) rather than a physical defect or contamination, and no injuries or illnesses are reported. This aligns with the 'Moderate' criteria for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Novus Scientific Ab is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs. The affected product is the TIGR Matrix Surgical Mesh, specifically Model Nos. NSTM1015, NSTM1520, and NSTM2030.
The recall involves 3,458 units total, with 657 units distributed in the United States. The product was distributed in the US states of Illinois, California, Florida, Kentucky, Missouri, New Hampshire, Virginia, Texas, North Carolina, Ohio, New York, and Tennessee, as well as in numerous countries worldwide including Sweden, Italy, Denmark, the UK, and Germany.
This action is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific hazard is related to the need for updated instructions for use regarding inguinal hernia repairs.
The recalled product
- Product
- TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
- Manufacturer
- Novus Scientific Ab
- Category
- Medical Device — Surgical Mesh
- Hazard
Distribution
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