FDAClass IIAugust 31, 2016

TIGR Matrix Surgical Mesh recall

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

Why was TIGR Matrix Surgical Mesh recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and identifiers are part of this recall.

Product
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Recalling firm
Novus Scientific Ab
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
Recall date
August 31, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls