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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64069

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 08, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Allergen Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0794-2013
Recall number
Z-0794-2013
Initiated
January 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Allergen Medical
Quantity
225 units (US) and 81 (Outside US)

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

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

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.