BEUDAMED
    FDA Recall Terminated

    Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.

    Recall: Z-1421-2013 · Initiated May 6, 2013

    Recall

    Recall Number
    Z-1421-2013
    Event Number
    65165
    Firm
    Alphatec Spine, Inc.
    FEI Number
    2027467
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 6, 2013
    Posted
    May 28, 2013
    Terminated
    September 25, 2014
    Address
    5818 El Camino Real, Carlsbad, CA, 92008-8816

    Description

    Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.

    Reason

    Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve

    Action

    Alphatec Spine initiated recall by contacting customers via telephone and/or email on 05/06/2013. An Urgent Medical Device Recall Notification letter along with a response form were sent via FedEx to all affected accounts. The letter identified the product, problem, and actions to be taken by the customers.

    Distribution

    Nationwide Distribution.

    Quantity

    1,814