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Recall Observatory FDA recall evidence

Device product

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

Z-0794-2013

January 08, 2013

Class II

Product summary

Firm
Allergen Medical
Event
Event 64069
Status
Terminated
Classification
Class II
Quantity
225 units (US) and 81 (Outside US)
Official record key
device-enforcement:Z-0794-2013

Official wording

Reason: Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured

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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    pouch, the outer pouch seal may be compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility may not be assured