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U.S. Department of Health and Human Services

Class 2 Device Recall AMS Ambicor

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  Class 2 Device Recall AMS Ambicor see related information
Date Initiated by Firm April 29, 2004
Create Date June 25, 2015
Recall Status1 Terminated 3 on October 31, 2005
Recall Number Z-0930-04
Recall Event ID 28972
Product Classification Prosthesis, Penis, Inflatable - Product Code JCW
Product AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450
Code Information Lot/serial number 361100/001-005
Recalling Firm/
Manufacturer		 American Medical Systems
10700 Bren Rd W
Minnetonka MN 55343-9679
For Additional Information Contact Randy Hoyt
952-930-6277
Manufacturer Reason
for Recall		 The product is mislabeled as to length.
FDA Determined
Cause 2		 Other
Action Recall letters, dated April 29, 2004, state that it is important for the consignees to contact the firm's customer service for an exchange of the recalled products for new product. The letters recommend that the consignees send an attached letter to physicians who implanted the products.
Quantity in Commerce 5 units
Distribution The affected products were distributed to consignees in the States of California and Texas, in Puerto Rico, and in the countries of Costa Rica and Taiwan.
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.
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