BEUDAMED
    FDA Recall 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 · Initiated April 6, 2017

    Recall

    Recall Number
    Z-1885-2017
    Event Number
    77069
    Firm
    Amendia, Inc
    FEI Number
    3007970248
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 6, 2017
    Posted
    April 25, 2017
    Terminated
    May 30, 2017
    Address
    1755 W Oak Pkwy, Marietta, GA, 30062-2260

    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.

    Action

    Amendia sent an Urgent Medical Device Recall Letter dated April 6, 2017, and April 25, 2017, to all affected customers. The letter requested that they check inventory, quarantine product for return to Amendia, and requested a sub-recall. The letter also included a reply form to be returned to Amendia. Customers with questions were instructed to call Amendia Customer Service at 770-575-5224. For questions regarding this recall call 404-610-7215.

    Distribution

    US distribution to GA, KS & TX

    Quantity

    15 units