American Medical Systems AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
Brand
American Medical Systems
Lot Codes / Batch Numbers
Lot Numbers: 527059 and 527061.
Products Sold
Lot Numbers: 527059 and 527061.
American Medical Systems is recalling AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Su due to 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 t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026