Recall Z-0702-2007 ยท FAE Prosthesis, Penile
American Medical Systems
AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN
| Date | Apr 3, 2007 (initiated Feb 19, 2007) |
| Status | Terminated |
| Reason | Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels. |
| Root cause | Other |
| Action | The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems. |
| Quantity | 5 devices |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953640 | DUNA II PENILE PROSTHESIS Dacomed Corp., Oct 27, 1995 |