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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65698

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 19, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Atrium Medical Corporation

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

4 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 4

C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.

Z-1936-2013
Recall number
Z-1936-2013
Initiated
July 19, 2013
Classification
Class II
Status
Terminated
Quantity
32,834 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Code information

Product lines with lot number 10405513 and higher

Distribution pattern

USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.

device · product 2 of 4

C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.

Z-1937-2013
Recall number
Z-1937-2013
Initiated
July 19, 2013
Classification
Class II
Status
Terminated
Quantity
1501 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Code information

Product lines with lot number 10405513 and higher

Distribution pattern

USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.

device · product 3 of 4

C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.

Z-1938-2013
Recall number
Z-1938-2013
Initiated
July 19, 2013
Classification
Class II
Status
Terminated
Quantity
95,286 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Code information

Product lines with lot number 10405513 and higher

Distribution pattern

USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.

device · product 4 of 4

C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.

Z-1939-2013
Recall number
Z-1939-2013
Initiated
July 19, 2013
Classification
Class II
Status
Terminated
Quantity
15,630 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Code information

Product lines with lot number 10405513 and higher

Distribution pattern

USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.