Z-1538-2015 Class II Terminated
FDA device recall Z-1538-2015 was initiated by Coloplast Manufacturing US, LLC on Apr 9, 2015 and is designated Class II. 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… The recall status is terminated (terminated Sep 11, 2015). Affected quantity: 11 (6 USA, 5 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2015
- Initiation Date
- Apr 9, 2015
- Termination Date
- Sep 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 (6 USA, 5 OUS)
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.
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.
Distribution Pattern
Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE
Code Information
4336612, 4364589 , 4413811, 4413812, 4336613, 4413810.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1538-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026