Novus Scientific Ab: Medical Device Recall in 2016 - (Recall #: Z-2603-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: July 19, 2016
Date Posted: August 31, 2016
Recall Number: Z-2603-2016
Event ID: 74801
Reason for Recall:

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

Status: Terminated
Product Quantity: 3458 units total (657 units in US)
Code Information:

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

Voluntary or Mandated:

Voluntary: Firm initiated