Class 2 Device Recall AMS 700 Penile Prothesis

• Date Initiated by Firm: February 09, 2007
• Date Posted: May 09, 2007
• Recall Status: Terminated on February 24, 2008
• Recall Number: Z-0788-2007
• Recall Event ID: 37437
• Product Classification: Penile Prothesis - Product Code JCW
• Product: AMS 700 CX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm product number 72404231. Penoscrotal Approach - with InhibiZone, 1 Pump, 2 Cylinders.
• Code Information: Lot # 473599
• Recalling Firm/ Manufacturer: American Medical Systems; 10700 Bren Rd W; Minnetonka MN 55343-9679
• Manufacturer Reason for Recall: The carton labeling does not match the product packaged inside.
• FDA Determined 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 in Commerce: 6
• Distribution: Worldwide, including USA, Canada and England.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.