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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74801

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

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Event summary

Timeline bucket
July 19, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Novus Scientific Ab

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

TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030

Z-2603-2016
Recall number
Z-2603-2016
Initiated
July 19, 2016
Classification
Class II
Status
Terminated
Recalling firm
Novus Scientific Ab
Quantity
3458 units total (657 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.

Code information

Unavailable

Distribution pattern

US : IL, CA, FL, KY, MO, NH, VA, TX, NC, OH, NY, TN, Worldwide: Sweden, Italy, Denmark, UK, Singapore, Germany, Belgium, Spain, Austria, Israel, Malta, Switzerland, Ireland, Norway, Netherlands, Turkey, New Zealand, Bulgaria, France, Iran, Finland, Poland, South Africa

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