FDA Enforcement
Class II
Terminated
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Recall: Z-0413-2022
·
Reported December 29, 2021
Enforcement
- Recall Number
- Z-0413-2022
- Event ID
- 89029
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Coloplast Manufacturing US, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 29, 2021
- Initiation Date
- November 9, 2021
- Classification Date
- December 22, 2021
- Termination Date
- September 29, 2025
- Address
- 1601 W River Rd, N/A, Minneapolis, MN, 55411-3431, United States
Description
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Reason
Product is mislabeled for size.
Code Info
SKU# 5206102400; Catalo # (450-1325); Lot 7685283
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.
Quantity
19 units