FDA recall Z-1374-2023

Coloplast Manufacturing US, LLC · Class II · device

Product

Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

Reason for recall

XXX

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-1374-2023