Device product
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Z-0413-2022
Product summary
- Event
- Event 89029
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-0413-2022
Official wording
Reason: Product is mislabeled for size.
Code information: SKU# 5206102400; Catalo # (450-1325); Lot 7685283
Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Canada.
Derived failure modes
-
Labeling or packaging
mislabeled