Recall Z-2603-2016 ยท FTL Mesh, Surgical, Polymeric
Novus Scientific Ab
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
| Date | Aug 19, 2016 (initiated Jul 19, 2016) |
| Status | Terminated |
| 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092224 | TIGR SURGICAL MESH , MODEL WK-6 Novus Scientific Pte, Ltd., Jan 25, 2010 |