PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 21, 2013 Initiated: July 19, 2013 #Z-1938-2013

Product Description

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

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

Details

Units Affected
95,286 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.
Location
Hudson, NH

Frequently Asked Questions

What product was recalled?
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.. Recalled by Atrium Medical Corporation. Units affected: 95,286 units.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1938-2013.