Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450

FDA Recall Z-0930-04 · Posted None

Recalling FirmAmerican Medical Systems
Recall StatusTerminated
Product CodeJCW
Date Initiated2004-04-29
Date Terminated2005-10-31
Product Quantity5 units

Reason for Recall

The product is mislabeled as to length.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑