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Class 2 Device Recall AMS 700 Penile Prothesis |
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Date Initiated by Firm |
February 09, 2007 |
Date Posted |
May 09, 2007 |
Recall Status1 |
Terminated 3 on February 24, 2008 |
Recall Number |
Z-0785-2007 |
Recall Event ID |
37437 |
Product Classification |
Penile Prothesis - Product Code JCW
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Product |
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. |
Code Information |
Lot # 472642 |
Recalling Firm/ Manufacturer |
American Medical Systems 10700 Bren Rd W Minnetonka MN 55343-9679
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Manufacturer Reason for Recall |
The carton labeling does not match the product packaged inside.
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FDA Determined Cause 2 |
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 |
4 |
Distribution |
Worldwide, including USA, Canada and England. |
Total Product Life Cycle |
TPLC Device Report
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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.
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