TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
FDA device recall Z-2603-2016 · posted 2016-08-19 · Terminated
Recall details
- Recalling firm
- Novus Scientific Ab
- Reason for recall
- Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 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, Turke
- Date initiated
- 2016-07-19
- Date posted
- 2016-08-19
- Date terminated
- 2016-12-23
- Location
- Uppsala, Sweden
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TIGR SURGICAL MESH , MODEL WK-6 (K092224) | Novus Scientific Pte, Ltd. | 2010-01-25 |