Device product

TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030

Z-2603-2016

July 19, 2016

Class II

Product summary

Firm: Novus Scientific Ab
Event: Event 74801
Status: Terminated
Classification: Class II
Quantity: 3458 units total (657 units in US)
Official record key: device-enforcement:Z-2603-2016

Official wording

Reason: Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.

Code information: Unavailable

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.