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Atrium Medical Corporation recalls C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Recalled August 21, 2013 · FDA recall Z-1937-2013 · Atrium Medical
Hazard
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 Class II
Units
1501 units
Sold at
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.
Description
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
Product
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Manufacturer(s)
Atrium Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →