Recall Z-0931-04 ยท JCW Prosthesis, Penis, Inflatable
American Medical Systems
AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451
| Date | Apr 29, 2004 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.