BEUDAMED
    FDA Enforcement Class II Terminated

    5.0mm Round Fluted Bur, Super Long

    Recall: Z-2204-2016 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-2204-2016
    Event ID
    74562
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2016
    Initiation Date
    June 16, 2016
    Classification Date
    July 14, 2016
    Termination Date
    June 6, 2017
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    Description

    5.0mm Round Fluted Bur, Super Long

    Reason

    Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.

    Code Info

    5190-010-050  5.0mm Round Fluted Bur, Super Long , Lot Number: 15322017

    Distribution

    US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands

    Quantity

    25