FDA Medical Device Recalls (openFDA)
Allergen Medical: SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
- Recall number
- Z-0794-2013
- Recalling firm
- Allergen Medical
- Product
- SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
- Status
- Terminated
- Initiated
- 2013-01-08
- Posted
- 2013-02-07
- Terminated
- 2013-07-29
- 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.
- Lot, serial or model codes
- Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)
- 510(k) numbers
- ["K080442"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 3008374097
- Firm city
- Medford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28