Recall Z-0935-2009 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc., Sub. C. R. Bard, Inc.
Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product Code: 0151531 Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use to the right or left side of the human body. There is a blue monofilament Medial marker "M" and a sm
| Date | Jan 28, 2009 (initiated Dec 8, 2008) |
| Status | Terminated |
| Reason | Mislabeled: Product labeled as Left large, may contain a Right Large |
| Root cause | Mixed-up of materials/components |
| Action | Davol issued a letter notification dated 12/25/08 via Federal Express requesting accounts discontinue use, remove product from inventory and return product. For additional information, contact Davol at 1-401-463-7000. |
| Quantity | 232 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K792281 | USHER'S MARLEX TUBULAR MESH Davol, Inc., Nov 27, 1979 |