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Terminated

Torosa Saline-Filled Testicular Prosthesis (Size Small)

FDA Recall Z-0413-2022 · Posted None

Recalling FirmColoplast Manufacturing US, LLC
Recall StatusTerminated
Product CodeFHW
Date Initiated2021-11-09
Date Terminated2025-09-29
Product Quantity19 units

Reason for Recall

Product is mislabeled for size.

Firm Action

A customer letter was issued to affected consignees dated 11/09/2021. Consignees are asked to move all inventory to quarantine and returned all impacted product within 10 days of letter receipt. If the product was further distributed, the consignee is directed to notify downstream customers of the recall. An Acknowledgement and Receipt Form should be completed indicating the quantity that will be returned. This should be completed even if there is no inventory.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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