BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1478-2022 · Initiated June 24, 2022

    Recall

    Recall Number
    Z-1478-2022
    Event Number
    90535
    Firm
    Stryker Instruments
    FEI Number
    3015967359
    Product Code
    HBE
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    June 24, 2022
    Address
    1941 Stryker Way, Portage, MI, 49002

    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.

    Action

    On June 24, 2022, the firm notified customers via Urgent Medical Device Recall Letters. Customers were instructed to locate and quarantine any affected products found in their inventory. Upon receiving the customer's completed response form, the firm will provide a shipping label to return any recalled product. Upon receipt of the recalled product, Stryker will contact the customer to arrange for replacement product.

    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