SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
FDA device recall Z-0794-2013 · posted 2013-02-07 · Terminated
Recall details
- Recalling firm
- Allergen Medical
- Reason for recall
- Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 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.
- Date initiated
- 2013-01-08
- Date posted
- 2013-02-07
- Date terminated
- 2013-07-29
- Location
- Medford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERISCAFFOLD SURGICAL MESH (K080442) | Serica Technologies, Inc. | 2008-11-13 |