Recall Z-0819-2014 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc., Subs. C. R. Bard, Inc.
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.
| Date | Jan 23, 2014 (initiated Jan 3, 2014) |
| Status | Terminated |
| Reason | Product labeling does not match product configuration. |
| Root cause | Labeling Change Control |
| Action | Davol, Inc., Subs. C. R. Bard, Inc.sent a customer notification letter on January 3, 2013, to all affected customers via Fedex to inform consignees that the Instructions for Use (IFU) and graphic contained on the inside of the product carton bottom references two features added to the inflation tube that are not present on the product they received. Please contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bards Medical Services & Support Department at 1-800-562-0027 if you have any questions. Consignees are asked to complete an effectiveness check form and return it via |
| Quantity | 19 |
| Distribution | Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102766 | COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM C.R. Bard, Inc., Dec 16, 2010 |