BEUDAMED
    FDA Enforcement Class II Completed

    Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-013-030DC

    Recall: Z-2727-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2727-2024
    Event ID
    95040
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2024
    Initiation Date
    July 24, 2024
    Classification Date
    August 26, 2024
    Address
    1941 Stryker Way, Portage, MI, 49002-9711, United States

    Description

    Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-013-030DC

    Reason

    Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.

    Code Info

    GTIN: 07613327501209 Lot Numbers: 22230017 22333017 22342017 23011017 23093017 23172017 23188017 23221017 23311017 24004027

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.

    Quantity

    2670 units