BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

    Recall: Z-1478-2022 · Reported August 3, 2022

    Enforcement

    Recall Number
    Z-1478-2022
    Event ID
    90535
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Instruments
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2022
    Initiation Date
    June 24, 2022
    Classification Date
    July 28, 2022
    Address
    1941 Stryker Way, Portage, MI, 49002, United States

    Description

    Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

    Reason

    There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.

    Code Info

    UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, Virginia and the countries of Canada, Netherlands, and Thailand.

    Quantity

    543