FDA recall Z-1375-2023

Product

Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; 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.

Distribution

Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.

Key facts

Status

Ongoing

Initiation date

2023-03-01

Report date

2023-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2023