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U.S. Department of Health and Human Services

Class 2 Device Recall TIGR Matrix Surgical Mesh

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  Class 2 Device Recall TIGR Matrix Surgical Mesh see related information
Date Initiated by Firm July 19, 2016
Date Posted August 19, 2016
Recall Status1 Terminated 3 on December 23, 2016
Recall Number Z-2603-2016
Recall Event ID 74801
510(K)Number K092224  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Code Information n/a
Recalling Firm/
Manufacturer		 Novus Scientific Ab
Virdings Alle 2
Uppsala Sweden
Manufacturer Reason
for Recall		 Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = NOVUS SCIENTIFIC PTE LTD
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