| Class 2 Device Recall TIGR Matrix Surgical Mesh | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FTL
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