C-QUR Mesh recall
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Why was C-QUR Mesh 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product lines with lot number 10405513 and higher
- Product
- C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 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.
- Recall date
- August 21, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)