Z-0703-2007

AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka...

Name: Z-0703-2007 AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka...
Creator: American Medical Systems
Published: 2007-02-19
License: https://open.fda.gov/license/

American Medical Systems, Inc. / initiated 2007-02-19 / Terminated / root cause: labeling and UDI

FDA source

American Medical Systems began a recall of AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN on 2007-02-19. The reason FDA records is "Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0703-2007
Status: Terminated
Initiated: 2007-02-19
Posted: 2007-04-03
Terminated: 2007-06-27
Recalling firm: American Medical Systems, Inc.
Product: AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN
Product code: FAE Prosthesis, Penile
Reason for recall: Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.
Quantity in commerce: 5 devices
Distribution: Nationwide
Product codes and lots: Lot 475175

Product code FAE

K953640Class IIDuna II Penile ProsthesisDacomed Corp. / cleared 1995-10-27

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)