Date Initiated by Firm |
February 19, 2007 |
Date Posted |
April 03, 2007 |
Recall Status1 |
Terminated 3 on June 27, 2007 |
Recall Number |
Z-0703-2007 |
Recall Event ID |
37615 |
510(K)Number |
K953640
|
Product Classification |
Penile Prosthesis Tip Extenders - Product Code FAE
|
Product |
AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN |
Code Information |
Lot 475175 |
Recalling Firm/ Manufacturer |
American Medical Systems 10700 Bren Rd W Minnetonka MN 55343-9679
|
Manufacturer Reason for Recall |
Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
|
FDA Determined Cause 2 |
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 in Commerce |
5 devices |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FAE and Original Applicant = DACOMED CORP.
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