AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm, product number 72404251. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders.
FDA Recall Z-0789-2007 · Posted 2007-05-09
Recalling FirmAmerican Medical Systems
Recall StatusTerminated
Product CodeJCW
Date Initiated2007-02-09
Date Terminated2008-02-24
Product Quantity10
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.