Recall Z-1019-04 ยท FTL Mesh, Surgical, Polymeric
American Medical Systems
Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
| Date | Jul 20, 2004 (initiated Jul 28, 2003) |
| Status | Terminated |
| Reason | Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles. |
| Root cause | Other |
| Action | The consignees were informed of the recall by telephone on 7/28/03 and told to return the product for replacement. |
| Quantity | 62 units |
| Distribution | The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023516 | MONARC SLING SYSTEM American Medical Systems, Inc., Nov 19, 2002 |