Z-0820-2014 Class II Terminated
FDA device recall Z-0820-2014 was initiated by Davol, Inc., Subs. C. R. Bard, Inc. on January 3, 2014 and is designated Class II. Reason for recall: Product labeling does not match product configuration. The recall status is terminated (terminated December 23, 2015). Affected quantity: 46.
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