AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
- Company
- American Medical Systems
- Recall Initiated
- January 28, 2008
- Posted
- July 16, 2008
- Terminated
- October 13, 2010
- Recall Number
- Z-1235-2008
- Firm Location
- W Minnetonka, MN
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot Numbers: 527059 and 527061.
Root Cause
Process control
Action Taken
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.