BEUDAMED
    FDA Enforcement Class II Terminated

    01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery

    Recall: Z-1885-2017 · Reported May 3, 2017

    Enforcement

    Recall Number
    Z-1885-2017
    Event ID
    77069
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amendia, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2017
    Initiation Date
    April 6, 2017
    Classification Date
    April 27, 2017
    Termination Date
    May 30, 2017
    Address
    1755 W Oak Pkwy, N/A, Marietta, GA, 30062-2260, United States

    Description

    01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery

    Reason

    Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.

    Code Info

    Lot Number 135561

    Distribution

    US distribution to GA, KS & TX

    Quantity

    15 units