FDAFDA · Food and drugs·Recall number Z-0413-2022
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Published December 29, 2021 · Recall initiated: November 9, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product is mislabeled for size.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Coloplast Manufacturing US, LLC
- Distributor
- Worldwide distribution - US Nationwide distribution and the country of Canada.
- Lot
- SKU# 5206102400; Catalo # (450-1325); Lot 7685283
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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