Z-1235-2008

AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support...

Name: Z-1235-2008 AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support...
Creator: American Medical Systems
Published: 2008-01-28
License: https://open.fda.gov/license/

American Medical Systems, Inc. / initiated 2008-01-28 / Terminated / root cause: manufacturing process

FDA source

American Medical Systems began a recall of AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System on 2008-01-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1235-2008
Status: Terminated
Initiated: 2008-01-28
Posted: 2008-07-16
Terminated: 2010-10-13
Recalling firm: American Medical Systems, Inc.
Product: AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
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.
Root cause tag: manufacturing process
FDA 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.
Product codes and lots: Lot Numbers: 527059 and 527061.

Product code MBI

K970292Class IIIn-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc. / cleared 1997-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)