Recall Z-0352-03 ยท 79F
Synovis Surgical Inovation Div. of
Surgical Mesh
| Date | Dec 11, 2002 |
| Status | Terminated |
| Reason | A gap in the exterior seal may lead to sterility concerns with the interior pouch. |
| Root cause | Other |
| Action | The sites and/or distributors that received suspect devices were contacted by telephone on 12/11/02 and given instructions on how to return/replace the devices. In addition, a letter dated 12/11/02 was sent to each consignee. |
| Quantity | 28 devices |
| Distribution | Product shipped nationwide, no foreign consignees |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002233 | BVI SLING Bio-Vascular, Inc., Oct 13, 2000 |