Recall Z-0794-2013 ยท FTL Mesh, Surgical, Polymeric
Allergen Medical
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
| Date | Feb 7, 2013 (initiated Jan 8, 2013) |
| Status | Terminated |
| Reason | Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured |
| Root cause | Packaging process control |
| Action | Allergan sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 8, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers are requested to quarantine and return any unused devices in inventory . In addition, customers are asked to complete and return the acknowledgement form. Customers with questions should contact Allergan at 781-658-2800, Mon- Fri, 9 a.m. to 5 p.m. EST. |
| Quantity | 225 units (US) and 81 (Outside US) |
| Distribution | Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080442 | SERISCAFFOLD SURGICAL MESH Serica Technologies, Inc., Nov 13, 2008 |