Coloplast Manufacturing US, LLC: Medical Device Recall in 2015 - (Recall #: Z-1538-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 9, 2015

Date Posted: May 6, 2015

Recall Number: Z-1538-2015

Event ID: 70960

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.

Status: Terminated

Product Quantity: 11 (6 USA, 5 OUS)

Code Information:

4336612, 4364589 , 4413811, 4413812, 4336613, 4413810.

Distribution Pattern:

Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE

Voluntary or Mandated:

Voluntary: Firm initiated