FDA Enforcement
Class II
Terminated
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Recall: Z-2603-2016
·
Reported August 31, 2016
Enforcement
- Recall Number
- Z-2603-2016
- Event ID
- 74801
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Novus Scientific Ab
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 31, 2016
- Initiation Date
- July 19, 2016
- Classification Date
- August 19, 2016
- Termination Date
- December 23, 2016
- Address
- Virdings Alle 2, Uppsala, N/A, Sweden
Description
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Reason
Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
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
Quantity
3458 units total (657 units in US)