FDA Medical Device Recalls (openFDA)
American Medical Systems: AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450
- Recall number
- Z-0930-04
- Recalling firm
- American Medical Systems
- Product
- AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450
- Status
- Terminated
- Initiated
- 2004-04-29
- Posted
- not on file
- Terminated
- 2005-10-31
- Reason
- The product is mislabeled as to length.
- 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
- 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.
- Lot, serial or model codes
- Lot/serial number 361100/001-005
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JCW
- Firm FEI
- 1000116179
- Firm city
- Minnetonka
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28