BEUDAMED
    FDA Enforcement Class II Ongoing

    Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14

    Recall: Z-2035-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2035-2023
    Event ID
    92357
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2023
    Initiation Date
    May 2, 2023
    Classification Date
    June 29, 2023
    Address
    250 Campus Dr, N/A, Marlborough, MA, 01752-3020, United States

    Description

    Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14

    Reason

    The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery

    Code Info

    UDI-DI: 15420045504066 Lot Number: E22H19RM

    Distribution

    US Nationwide distribution.

    Quantity

    756 units