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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-0789-2007
Recall Event ID 37437
Product Classification Penile Prothesis - Product Code JCW
Product 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.
Code Information Lot # 474230
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 10
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.