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U.S. Department of Health and Human Services

Class 2 Device Recall InFast Ultra Transvaginal Bladder Neck Support System

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  Class 2 Device Recall InFast Ultra Transvaginal Bladder Neck Support System see related information
Date Initiated by Firm January 28, 2008
Date Posted July 16, 2008
Recall Status1 Terminated 3 on October 13, 2010
Recall Number Z-1235-2008
Recall Event ID 46833
510(K)Number K970292  
Product Classification Fastener, Fixation, Nondegradable, Soft Tissue - Product Code MBI
Product AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
Code Information Lot Numbers: 527059 and 527061.
Recalling Firm/
American Medical Systems
10700 Bren Rd W
Minnetonka MN 55343-9679
For Additional Information Contact
Manufacturer Reason
for Recall
Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.
FDA Determined
Cause 2
Process control
Action All customers received phone calls on 1/28/08 explaining the error and associated risks and were followed up with detailed letters. The letter "AMS Important Product Recall" dated 1/28/08 described the product and problem. Customers were advised to return the enclosed "Recall Acknowledgement Form" to AMS along with any affected product that they have in inventory.
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MBI and Original Applicant = INFLUENCE, INC.