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U.S. Department of Health and Human Services

Class 2 Device Recall Genesis Malleable Penile Prosthesis

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  Class 2 Device Recall Genesis Malleable Penile Prosthesis see related information
Date Initiated by Firm April 09, 2015
Date Posted April 27, 2015
Recall Status1 Terminated 3 on September 11, 2015
Recall Number Z-1538-2015
Recall Event ID 70960
510(K)Number K040959  
Product Classification Prosthesis, penile - Product Code FAE
Product Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250.

Product Usage:
The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.
Code Information 4336612, 4364589 , 4413811, 4413812, 4336613, 4413810.    
Recalling Firm/
Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.
FDA Determined
Cause 2
Error in labeling
Action Consignees were notified via Field Representatives starting on 4-9-2015 with a Coloplast "Urgent Correction Notification" letter dated April 7, 2015. The letter described the problem and the product involved in the recall. Requested consignees to complete the Return Form if returning inventory. For questions contact Customer Service at 800-258-3476.
Quantity in Commerce 11 (6 USA, 5 OUS)
Distribution Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE
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.
510(K) Database 510(K)s with Product Code = FAE and Original Applicant = MENTOR CORP.