BEUDAMED
    FDA Recall Completed

    Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

    Recall: Z-0669-2025 · Initiated October 10, 2022

    Recall

    Recall Number
    Z-0669-2025
    Event Number
    95781
    Firm
    Hologic, Inc
    FEI Number
    1000120743
    Product Code
    FZX
    Status
    Completed
    Root Cause
    Labeling Change Control
    Initiated
    October 10, 2022
    Posted
    December 11, 2024
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020

    Description

    Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

    Reason

    IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set

    Action

    Hologic issued Letter-Revised Sterilization Instructions for Sizer Set on 10/10/22 via Fed'X. The letter states reason for recall, health risk and action to take: Effective immediately, please steam autoclave F0101 in accordance with such IFU, subject to the following parameters. Any additional parameters contained in Hologic s IFU for F0101 should no longer be utilized. link to their Instructions for Use (IFU) below: https://summitmedicalusa.com/wordpress/wp-content/uploads/2021/05/40192-01_RevZ_IS-IFU_Multilingual.pdf Please also note that when sterilizing F0101, one (1) layer of wrapping material (or one layer of 1 ply wrap) is necessary to provide a sterile barrier for each sterilization tray. Please do not utilize 2 layers or one layer of 2-ply wrap. In the future, Hologic will be updating the IFU supplied with the sizers within F0101, to reflect this change. mailto:[email protected]

    Distribution

    US Nationwide distribution.

    Quantity

    178 units