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U.S. Department of Health and Human Services

Class 2 Device Recall AMS 700 Penile Prothesis

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  Class 2 Device Recall AMS 700 Penile Prothesis see related information
Date Initiated by Firm February 09, 2007
Date Posted May 09, 2007
Recall Status1 Terminated 3 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/
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 2
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.