Z-0820-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2014
- Initiation Date
- January 3, 2014
- Termination Date
- December 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46
Product Description
Composix L/P with Echo PS 6" X 8" Product Code 0144680 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.
Reason for Recall
Product labeling does not match product configuration.
Distribution Pattern
Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
Code Information
Lot# HUXG0491, HUXH0295