Device product
Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
Z-0819-2014
Product summary
- Event
- Event 67149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19
- Official record key
device-enforcement:Z-0819-2014
Official wording
Reason: Product labeling does not match product configuration.
Code information: Lot# HUXH0294
Distribution pattern: Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
Derived failure modes
-
Unknown
Product labeling does not match product configuration.