FDA-Device2021-12-29Class II
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Coloplast Manufacturing US, LLC
Hazard
Product is mislabeled for size.
Sold states
Worldwide distribution - US Nationwide distribution and the country of Canada.
Affected count
19 units
Manufactured in
1601 W River Rd, N/A, Minneapolis, MN, United States
Products
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0413-2022Don't want to check this manually?
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