Z-2603-2016 Class II Terminated
FDA device recall Z-2603-2016 was initiated by Novus Scientific Ab on July 19, 2016 and is designated Class II. Reason for recall: Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs. The recall status is terminated (terminated December 23, 2016). Affected quantity: 3458 units total (657 units in US).
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