Coloplast Manufacturing US, LLC: Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis

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.

Details from the source

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. Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. Quantity: 2 units Lot/code info: UDI/DI 05708932072595, Lot Numbers: 8887620, 8939124

UPC codes

05708932072595

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.