Z-1538-2015Class II

Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250

Name: Z-1538-2015 Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250
Creator: Coloplast Manufacturing US, LLC
Published: 2015-04-09
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2015-04-09 / Terminated / root cause: labeling and UDI

FDA source

Coloplast Manufacturing US, LLC began a recall of Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible... on 2015-04-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1538-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-09
Posted: 2015-04-27
Terminated: 2015-09-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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 code: FAE Prosthesis, Penile
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 11 (6 USA, 5 OUS)
Distribution: Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE
Product codes and lots: 4336612, 4364589 , 4413811, 4413812, 4336613, 4413810.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1538-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1538-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27

Product code FAE

K040959Class IIMentor Genesis Penile ProsthesisMentor Corp. / cleared 2004-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)