Recall Z-1380-2011 ยท FTM Mesh, Surgical
Davol, Inc., Sub. C. R. Bard, Inc.
XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 15 x 20 cm Rectangle Catalog #: 1161520
| Date | Mar 2, 2011 (initiated Jan 7, 2011) |
| Status | Terminated |
| Reason | Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria. |
| Root cause | Process control |
| Action | Davol issued recall notification to accounts by letter dated 1/06/11 requesting recalled units be returned. contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. A fax sheet attached to the letter to be completed and fax to 1-401-825-8753. |
| Quantity | 1492 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081272 | PORCINE SURGICAL MESH; DERMAL MATRIX Brennen Medical, LLC, Jul 31, 2008 |