Recall Z-0795-2007 ยท FTM Mesh, Surgical
Ethicon, Inc.
Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
| Date | May 10, 2007 (initiated Apr 20, 2007) |
| Status | Terminated |
| Reason | The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01) |
| Root cause | Other |
| Action | Recall notifications were sent by 2nd day air UPS delivery on April 20, 2007 to all hospitals Director of Surgery, OR Managers and Materials Managers. |
| Quantity | 160 units to US |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013718 | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR Gynecare, A Div. of Ethicon, Inc., Jan 8, 2002 |