Z-0794-2013Class II

SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic...

Name: Z-0794-2013 SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic...
Creator: Allergen Medical
Published: 2013-01-08
License: https://open.fda.gov/license/

Allergen Medical / initiated 2013-01-08 / Terminated / root cause: packaging

FDA source

Allergen Medical began a recall of SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures on 2013-01-08. FDA classified it as Class II and gives the reason as "Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0794-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-08
Posted: 2013-02-07
Terminated: 2013-07-29
Recalling firm: Allergen Medical
Product: SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Product code: FTL Mesh, Surgical, Polymeric
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
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0794-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0794-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-07

Product code FTL

K080442Class IISeriscaffold Surgical MeshSerica Technologies, Inc. / cleared 2008-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)