Recall Z-0785-2007 ยท JCW Prosthesis, Penis, Inflatable
American Medical Systems
AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Tactile Pump, 2 Cylinders.
| Date | May 9, 2007 (initiated Feb 9, 2007) |
| Status | Terminated |
| Reason | The carton labeling does not match the product packaged inside. |
| Root cause | Other |
| Action | AMS has contacted every account (via e-mail 2/9/2007) that either purchased or implanted the affected product. Unused pieces have been recovered and scrapped. |
| Quantity | 4 |
| Distribution | Worldwide, including USA, Canada and England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.