FDA-Device2023-04-19Class II
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Coloplast Manufacturing US, LLC
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
Affected count
23 units
Manufactured in
1601 W River Rd, N/A, Minneapolis, MN, United States
Products
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2023Don't want to check this manually?
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