Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item… recallZ-1538-2015 · Coloplast Manufacturing US, LLC · initiated Apr 9, 2015
Class II Terminated All recalls posted in April 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Coloplast Manufacturing US, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-1538-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 9, 2015
- Posted by the FDA
- Apr 27, 2015
- Recalling firm
- Coloplast Manufacturing US, LLC
- Quantity
- 11 (6 USA, 5 OUS)
- Product code
- FAE
- FDA submissions
- K040959
- Distribution
- Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE
Product description
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 (models, lots, serial numbers)
4336612, 4364589 , 4413811, 4413812, 4336613, 4413810.
Other devices under the same FDA submission
3 devices cleared under K040959 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Genesis 91-9511SCColoplast A/S · PROSTHESIS, PENILE85 reports
- Genesis 91-9509SCColoplast A/S · PROSTHESIS, PENILE49 reports
- Genesis 91-9513SCColoplast A/S · PROSTHESIS, PENILE28 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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