Genesis Malleable Penile Prosthesis recalled over labeling errors

Recall date

April 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Coloplast Manufacturing US, LLC recalls Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesi…

Recall number

Z-1538-2015

FDA classification

Class II

Brand / firm

Coloplast Manufacturing US, LLC

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.