AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
FDA device recall Z-1235-2008 · posted 2008-07-16 · Terminated
Recall details
- Recalling firm
- American Medical Systems
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MBI
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-01-28
- Date posted
- 2008-07-16
- Date terminated
- 2010-10-13
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW (K970292) | Influence, Inc. | 1997-04-23 |