FDA recall Z-0413-2022
Coloplast Manufacturing US, LLC · Class II · device
Product
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Reason for recall
Product is mislabeled for size.
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.
Key facts
- Status
- Terminated
- Initiation date
- 2021-11-09
- Report date
- 2021-12-29
- Termination date
- 2025-09-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Minneapolis, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0413-2022