TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
FDA Recall Z-2603-2016 · Posted 2016-08-19
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Recalling FirmNovus Scientific Ab
Recall StatusTerminated
Product CodeFTL
Date Initiated2016-07-19
Date Terminated2016-12-23
Product Quantity3458 units total (657 units in US)
Reason for Recall
Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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