Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Reported: April 19, 2023 Initiated: March 1, 2023 #Z-1363-2023
Product Description
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Reason for Recall
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Details
- Recalling Firm
- Coloplast Manufacturing US, LLC
- Units Affected
- 2 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis. Recalled by Coloplast Manufacturing US, LLC. Units affected: 2 units.
Why was this product recalled? ▼
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Moderate. Recall number: Z-1363-2023.
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