Device product
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Z-1937-2013
Product summary
- Event
- Event 65698
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1501 units
- Official record key
device-enforcement:Z-1937-2013
Official wording
Reason: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
Code information: Product lines with lot number 10405513 and higher
Distribution pattern: 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.
Derived failure modes
-
Unknown
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions