FDA Medical Device Recalls (openFDA)
Novus Scientific Ab: TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
- Recall number
- Z-2603-2016
- Recalling firm
- Novus Scientific Ab
- Product
- TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
- Status
- Terminated
- Initiated
- 2016-07-19
- Posted
- 2016-08-19
- Terminated
- 2016-12-23
- Reason
- Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
- 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
- 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
- Lot, serial or model codes
- n/a
- 510(k) numbers
- ["K092224"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 3010187263
- Firm city
- Uppsala
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28