Recall Z-0360-2007 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc., Sub. C. R. Bard, Inc.
Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204
| Date | Jan 30, 2007 (initiated Jan 10, 2007) |
| Status | Completed |
| Reason | PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula |
| Root cause | Other |
| Action | Davol Inc. notified Hospital Administrators/Risk Health Managers,distributors, and surgeons of the expanded recall by letter beginning 1/10/07. Product under recall is to be returned to Davol for replacement. Davol is posting recall information to their website. |
| Quantity | 16,603 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 Davol, Inc., Jan 22, 2001 |