Date Initiated by Firm | April 29, 2004 |
Create Date | June 25, 2015 |
Recall Status1 |
Terminated 3 on October 31, 2005 |
Recall Number | Z-0931-04 |
Recall Event ID |
28972 |
Product Classification |
Prosthesis, Penis, Inflatable - Product Code JCW
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Product | AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451 |
Code Information |
Lot/serial number 361101/001-005 |
Recalling Firm/ Manufacturer |
American Medical Systems 10700 Bren Rd W Minnetonka MN 55343-9679
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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 |
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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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