BEUDAMED
    FDA Recall Terminated

    Stryker 5.0mm Egg Bur 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-1766-2014 · Initiated May 22, 2014

    Recall

    Recall Number
    Z-1766-2014
    Event Number
    68331
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 22, 2014
    Posted
    June 11, 2014
    Terminated
    May 6, 2015
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Stryker 5.0mm Egg Bur 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.

    Action

    Stryker Instruments sent an URGENT MEDICAL DEVICE RECALL notification letter dated May 22, 2014, to the consignees. Recall notification included affected product description and identification, reason for recall, risk to health, and actions to be taken by the customers. Customers will be instructed to review the notification, quarantine unused product and to return a signed Business Reply Form. They will be advised that a Stryker Representative will be sent to their facility to inspect any affected product on hand. Once product is inspected by the Stryker Representative, they can return conforming product back to stock, for normal use. Non-conforming product will be removed from the facility by a Stryker Representative following the inspection process. The Stryker Representative will send the product to the manufacturer for destruction. For questions regarding this recall please contact Stryker Instruments: Kara Spath 269-389-4518 [email protected]

    Distribution

    Worldwide Distribution - US (nationwide)

    Quantity

    144