BEUDAMED
    FDA Enforcement Class II Terminated

    Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

    Recall: Z-1133-2017 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1133-2017
    Event ID
    76130
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Advanced Energy, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2017
    Initiation Date
    December 28, 2016
    Classification Date
    February 2, 2017
    Termination Date
    May 11, 2017
    Address
    180 International Dr, N/A, Portsmouth, NH, 03801-6837, United States

    Description

    Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

    Reason

    Product sterility compromised due to breach of sterile barrier

    Code Info

    All lot codes

    Distribution

    Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.

    Quantity

    275 units