BEUDAMED
    FDA Enforcement Class II Terminated

    Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

    Recall: Z-1735-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1735-2019
    Event ID
    82856
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 12, 2019
    Initiation Date
    November 14, 2018
    Classification Date
    June 5, 2019
    Termination Date
    May 12, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

    Reason

    Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.

    Code Info

    Lot M26888

    Distribution

    US Distribution to CA, NC, and NY; and International to Germany.

    Quantity

    64