Coloplast Genesis Malleable Penile Prosthesis Mislabeled Size Recall
Coloplast is recalling 11 units of the 9.5 mm Genesis Malleable Penile Prosthesis because the retail box and patient labels incorrectly state the size as 9 mm.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where the patient label does not match the device size. This fits the rubric for moderate severity, as it is a labeling error without reported injuries or illnesses.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling 11 units of the Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog/Item Number 91-9509SC/519250. The recall involves six units in the United States and five units outside the US. The affected lots are identified by the following codes: 4336612, 4364589, 4413811, 4413812, 4336613, and 4413810.
The recall was initiated because the retail box and patient labels for these specific units indicate a size of 9 mm, whereas the actual device size is 9.5 mm. The correct size, 9.5 mm, is printed directly on the individual prosthesis tray during the packaging process. The device is a flexible silicone elastomer implant designed for the management of erectile dysfunction.
The affected units were distributed worldwide, with US distribution in Florida, New York, and Texas, and distribution in France. Patients who have received this device should contact their healthcare provider to verify the size of the implanted prosthesis against the device tray label.
The recalled product
- 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.
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 4336612
- 4364589
- 4413811
- 4413812
- 4336613
- 4413810.
Distribution
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