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U.S. Department of Health and Human Services

Class 2 Device Recall AMS DURAII Distil Tips

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 Class 2 Device Recall AMS DURAII Distil Tipssee related information
Date Initiated by FirmFebruary 19, 2007
Date PostedApril 03, 2007
Recall Status1 Terminated 3 on June 27, 2007
Recall NumberZ-0703-2007
Recall Event ID 37615
510(K)NumberK953640 
Product Classification Penile Prosthesis Tip Extenders - Product Code FAE
ProductAMS 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
ActionThe consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.
Quantity in Commerce5 devices
DistributionNationwide
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = FAE
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