Z-2603-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2016
- Initiation Date
- July 19, 2016
- Termination Date
- December 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3458 units total (657 units in US)
Product Description
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Reason for Recall
Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
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