C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Reported: August 21, 2013 Initiated: July 19, 2013 #Z-1936-2013
Product Description
C-QUR Mesh (All Sizes, 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
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 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.
- Location
- Hudson, NH
Frequently Asked Questions
What product was recalled? ▼
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.. Recalled by Atrium Medical Corporation. Units affected: 32,834 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-1936-2013.
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