CLASS II Device recall · Reported 21 Aug 2013 · FDA Enforcement Report

C-qur TacShield Mesh (All sizes and shapes) recalled by Atrium Medical

Atrium Medical is recalling C-qur TacShield Mesh (All sizes and shapes), distributed nationwide in the US. The recall was initiated on 19 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct lines with lot number 10405513 and higher

Quantity recalled15,630 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1939-2013
FDA event ID: 65698
Recalling firm: Atrium Medical, Hudson, NH
Classification: Class II
Status: Terminated
Recall initiated: 19 Jul 2013
FDA classified: 9 Aug 2013
Reported: 21 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

19 Jul 2013	Recall initiated by company
9 Aug 2013	Classified by FDA	+21 days
21 Aug 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Product lines with lot number 10405513 and higher

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 65698

This product is part of a recall event; the main page for the event is C-qur Edge Mesh (All sizes and shapes) recalled by Atrium Medical.

Reported	Class	Recall	Company	Reason	Where
21 Aug 2013	CLASS II	C-qur Edge Mesh (All sizes and shapes) recalled by Atrium Medical	Atrium Medical	Packaging Defects	Nationwide
21 Aug 2013	CLASS II	C-qur V-Patch Mesh (All sizes and shapes) recalled by Atrium Medical	Atrium Medical	Packaging Defects	Nationwide
21 Aug 2013	CLASS II	C-qur Mesh (All Sizes, shapes) recalled by Atrium Medical	Atrium Medical	Packaging Defects	Nationwide

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