FDA Enforcement
Class II
Terminated
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.
Recall: Z-1538-2015
·
Reported May 6, 2015
Enforcement
- Recall Number
- Z-1538-2015
- Event ID
- 70960
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Coloplast Manufacturing US, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- May 6, 2015
- Initiation Date
- April 9, 2015
- Classification Date
- April 27, 2015
- Termination Date
- September 11, 2015
- Address
- 1601 W River Rd, Minneapolis, MN, 55411-3431, United States
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
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.
Code Info
4336612, 4364589 , 4413811, 4413812, 4336613, 4413810.
Distribution
Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE
Quantity
11 (6 USA, 5 OUS)