American Medical Systems AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450
Brand
American Medical Systems
Lot Codes / Batch Numbers
Lot/serial number 361100/001-005
Products Sold
Lot/serial number 361100/001-005
American Medical Systems is recalling AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number due to The product is mislabeled as to length.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product is mislabeled as to length.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, TX, PR
Page updated: Jan 10, 2026