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.
FDA Recall Z-1538-2015 · Posted 2015-04-27
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Recalling FirmColoplast Manufacturing US, LLC
Recall StatusTerminated
Product CodeFAE
Date Initiated2015-04-09
Date Terminated2015-09-11
Product Quantity11 (6 USA, 5 OUS)
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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