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Coloplast Manufacturing US, LLC recalls Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
Recalled April 19, 2023 · FDA recall Z-1373-2023 · Coloplast Manufacturing US
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. · FDA Class II
Units
25 units
Sold at
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
Description
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.
Product
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
Manufacturer(s)
Coloplast Manufacturing US, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →