Recall Z-1538-2015 ยท FAE Prosthesis, Penile
Coloplast Manufacturing US, LLC
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.
| Date | Apr 27, 2015 (initiated Apr 9, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 11 (6 USA, 5 OUS) |
| Distribution | Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040959 | MENTOR GENESIS PENILE PROSTHESIS Mentor Corp., Oct 29, 2004 |