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.
FDA Recall Z-0785-2007 · Posted 2007-05-09
Recalling FirmAmerican Medical Systems
Recall StatusTerminated
Product CodeJCW
Date Initiated2007-02-09
Date Terminated2008-02-24
Product Quantity4
Reason for Recall
The carton labeling does not match the product packaged inside.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Canada and England.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.