BEUDAMED
    FDA Enforcement Class II Terminated

    Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    Recall: Z-0882-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0882-2017
    Event ID
    75858
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amendia, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    November 22, 2016
    Classification Date
    December 22, 2016
    Termination Date
    February 1, 2024
    Address
    1755 W Oak Pkwy, N/A, Marietta, GA, 30062-2260, United States

    Description

    Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    Reason

    The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

    Code Info

    Part Number 812-11R-15 Lot Number 121945, 123231, 124146, 125418, 126822, 127868, 128459, 128464, 130818, 131492, 13496, 132594, 132813, 134514, 134515, 134517, 134909, 135290, 137302

    Distribution

    Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico

    Quantity

    1078 units