BEUDAMED
    FDA Recall Terminated

    Torosa Saline-Filled Testicular Prosthesis (Size Small)

    Recall: Z-0413-2022 · Initiated November 9, 2021

    Recall

    Recall Number
    Z-0413-2022
    Event Number
    89029
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    FHW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 9, 2021
    Terminated
    September 29, 2025
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3431

    Description

    Torosa Saline-Filled Testicular Prosthesis (Size Small)

    Reason

    Product is mislabeled for size.

    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.

    Distribution

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

    Quantity

    19 units