Recall Z-1235-2008 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
American Medical Systems
AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
| Date | Jul 16, 2008 (initiated Jan 28, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970292 | IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW Influence, Inc., Apr 23, 1997 |