Z-0413-2022 Class II Terminated
FDA device recall Z-0413-2022 was initiated by Coloplast Manufacturing US, LLC on Nov 9, 2021 and is designated Class II. Reason for recall: Product is mislabeled for size. The recall status is terminated (terminated Sep 29, 2025). Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 29, 2021
- Initiation Date
- Nov 9, 2021
- Termination Date
- Sep 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Reason for Recall
Product is mislabeled for size.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the country of Canada.
Code Information
SKU# 5206102400; Catalo # (450-1325); Lot 7685283
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0413-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026