Allergen Medical: Medical Device Recall in 2013 - (Recall #: Z-0794-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 8, 2013

Date Posted: February 13, 2013

Recall Number: Z-0794-2013

Event ID: 64069

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

Status: Terminated

Product Quantity: 225 units (US) and 81 (Outside US)

Code Information:

Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated