TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520… recallZ-2603-2016 · Novus Scientific Ab · initiated Jul 19, 2016
Class II Terminated All recalls posted in August 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Novus Scientific Ab or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-2603-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 19, 2016
- Posted by the FDA
- Aug 19, 2016
- Recalling firm
- Novus Scientific Ab
- Quantity
- 3458 units total (657 units in US)
- Product code
- FTL
- FDA submissions
- K092224
- 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
Code information (models, lots, serial numbers)
n/a
Other devices under the same FDA submission
1 device cleared under K092224 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TIGR® Matrix Surgical Mesh NSTM2030Novus Scientific AB · Mesh, Surgical, Polymeric1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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