Z-0931-04

AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451

Name: Z-0931-04 AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451
Creator: American Medical Systems
Published: 2004-04-29
License: https://open.fda.gov/license/

American Medical Systems, Inc. / initiated 2004-04-29 / Terminated / root cause: labeling and UDI

FDA source

American Medical Systems began a recall of AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451 on 2004-04-29. The reason FDA records is "The product is mislabeled as to length". 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-0931-04
Status: Terminated
Initiated: 2004-04-29
Posted: 2015-06-25
Terminated: 2005-10-31
Recalling firm: American Medical Systems, Inc.
Product: AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451
Product code: JCW Prosthesis, Penis, Inflatable
Reason for recall: The product is mislabeled as to length.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recall letters, dated April 29, 2004, state that it is important for the consignees to contact the firm's customer service for an exchange of the recalled products for new product. The letters recommend that the consignees send an attached letter to physicians who implanted the products.
Quantity in commerce: 5 units
Distribution: The affected products were distributed to consignees in the States of California and Texas, in Puerto Rico, and in the countries of Costa Rica and Taiwan.
Product codes and lots: Lot/serial number 361101/001-005

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)