Z-1936-2013Class II

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

Name: Z-1936-2013 C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies
Creator: Atrium Medical Corporation
Published: 2013-07-19
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2013-07-19 / Terminated / root cause: packaging

FDA source

Atrium Medical Corporation began a recall of C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies on 2013-07-19. FDA classified it as Class II and gives the reason as "Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1936-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-19
Posted: 2013-08-09
Terminated: 2016-03-18
Recalling firm: Atrium Medical Corporation
Product: C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Product code: FTL Mesh, Surgical, Polymeric
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
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Atrium Medical issued Recall Letter via UPS and e-mail on 7/19/13 to the accounts and field representatives. The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. A reply for is requested to be completed to acknowledge receipt to the notification. Additional language to the instructions for use (IFU) to include: Prolonged exposure to high humidity may result in increased rate of adherence of the C-QUR mesh to its handling sleeve. Store in a Controlled Room Temperature (25 C / 77 F ) or less. Brief exposure to up to 40 C (104 F ) is acceptable. Questions please contact Atrium Medical Customer Service at 1- 800- 528-7486 Monday through Friday 9:00 am to 5:00 pm EDT.
Quantity in commerce: 32,834 units
Distribution: 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.
Product codes and lots: Product lines with lot number 10405513 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1936-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1936-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1937-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1938-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1939-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09

Product code FTL

K050311Class IIAtrium Medical Corporation C-Qur MeshAtrium Medical Corp. / cleared 2006-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)