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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: August 9, 2013
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Affected Products

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

Product lines with lot number 10405513 and higher

Lot Numbers:
number
Product: C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.

Product lines with lot number 10405513 and higher

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

Product lines with lot number 10405513 and higher

Lot Numbers:
number
Product: C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.

Product lines with lot number 10405513 and higher

Lot Numbers:
number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 65698
Status: Resolved
Manufacturer: Atrium Medical Corporation
Manufactured In: United States
Units Affected: 4 products (32,834 units; 1501 units; 95,286 units; 15,630 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.