# FDA recall Z-0413-2022

> **Coloplast Manufacturing US, LLC** · Class II · device recall initiated 2021-11-09.

## 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

- **Recall number:** Z-0413-2022
- **Recalling firm:** Coloplast Manufacturing US, LLC
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0413-2022

## Citation

> AI Analytics. FDA recall Z-0413-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0413-2022. Source: US FDA. Licensed CC0.

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