BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.

    Recall: Z-0828-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0828-2016
    Event ID
    73180
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    December 18, 2015
    Classification Date
    February 19, 2016
    Termination Date
    August 1, 2016
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    Description

    Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.

    Reason

    Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.

    Code Info

    Lot #144933, 14D252, and 14D253.

    Distribution

    Nationwide Distribution

    Quantity

    31 units