BEUDAMED
    FDA Enforcement Class II Terminated

    50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    Recall: Z-1040-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1040-2016
    Event ID
    73172
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2016
    Initiation Date
    February 4, 2016
    Classification Date
    March 3, 2016
    Termination Date
    May 9, 2017
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    Reason

    During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

    Code Info

    50001 Lot numbers: 61303001, 61309001, 61310001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.

    Distribution

    Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.

    Quantity

    5,800 units total