C-QUR TacShield Mesh (All sizes and shapes) recallZ-1939-2013 · Atrium Medical Corporation · initiated Jul 19, 2013
Class II Terminated All recalls posted in August 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Atrium Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Package design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-1939-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 19, 2013
- Posted by the FDA
- Aug 9, 2013
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 15,630 units
- Product code
- FTL
- FDA submissions
- K100076
- 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 description
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Code information (models, lots, serial numbers)
Product lines with lot number 10405513 and higher
Other devices under the same FDA submission
5 devices cleared under K100076 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- C-QUR TACSHIELD 31633Atrium Medical Corporation · Mesh, surgical, polymeric12 reports
- C-QUR TACSHIELD 31628Atrium Medical Corporation · Mesh, surgical, polymeric8 reports
- C-QUR TACSHIELD 31610Atrium Medical Corporation · Mesh, surgical, polymeric6 reports
- C-QUR TACSHIELD 31636Atrium Medical Corporation · Mesh, surgical, polymeric5 reports
- C-QUR TACSHIELD 31626Atrium Medical Corporation · Mesh, surgical, polymeric3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 65698).
- Z-1936-2013 · TerminatedC-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
- Z-1937-2013 · TerminatedC-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
- Z-1938-2013 · TerminatedC-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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