Z-0785-2007

AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924...

Name: Z-0785-2007 AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924...
Creator: American Medical Systems
Published: 2007-02-09
License: https://open.fda.gov/license/

American Medical Systems, Inc. / initiated 2007-02-09 / Terminated / root cause: labeling and UDI

FDA source

American Medical Systems began a recall of AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8... on 2007-02-09. The reason FDA records is "The carton labeling does not match the product packaged inside". 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-0785-2007
Status: Terminated
Initiated: 2007-02-09
Posted: 2007-05-09
Terminated: 2008-02-24
Recalling firm: American Medical Systems, Inc.
Product: AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Tactile Pump, 2 Cylinders.
Product code: JCW Prosthesis, Penis, Inflatable
Reason for recall: The carton labeling does not match the product packaged inside.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: AMS has contacted every account (via e-mail 2/9/2007) that either purchased or implanted the affected product. Unused pieces have been recovered and scrapped.
Quantity in commerce: 4
Distribution: Worldwide, including USA, Canada and England.
Product codes and lots: Lot # 472642

Product code JCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)