BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

    Recall: Z-1774-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1774-2014
    Event ID
    68331
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    June 18, 2014
    Initiation Date
    May 22, 2014
    Classification Date
    June 10, 2014
    Termination Date
    May 6, 2015
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

    Reason

    There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

    Code Info

    Part Number 5820-107-25, Lot Number 13346017

    Distribution

    Worldwide Distribution - US (nationwide)

    Quantity

    41