Z-2603-2016Class II

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

Name: Z-2603-2016 TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Creator: Novus Scientific Ab
Published: 2016-07-19
License: https://open.fda.gov/license/

Novus Scientific AB / initiated 2016-07-19 / Terminated / root cause: labeling and UDI

FDA source

Novus Scientific Ab began a recall of TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030 on 2016-07-19. FDA classified it as Class II and gives the reason as "Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2603-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-19
Posted: 2016-08-19
Terminated: 2016-12-23
Recalling firm: Novus Scientific AB
Product: TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 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
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2603-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2603-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

Product code FTL

K092224Class IITigr Surgical Mesh , Model Wk-6Novus Scientific Pte, Ltd. / cleared 2010-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)