BEUDAMED
    FDA Recall Open, Classified

    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

    Recall: Z-0981-2025 · Initiated June 28, 2023

    Recall

    Recall Number
    Z-0981-2025
    Event Number
    95998
    Firm
    Stryker Corporation
    FEI Number
    3015967359
    Product Code
    HBE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 28, 2023
    Posted
    January 17, 2025
    Address
    1941 Stryker Way, Portage, MI, 49002-9711

    Description

    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

    Reason

    There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

    Action

    Stryker issued a Medical Device Recall notice to its consignees on 06/28/2024 via FedEx. The notice explained the issue and requested the following: "Actions to be taken 1. Review your inventory to locate and quarantine any affected products found on-hand. 2. Sign and return the enclosed Business Response Form (BRF), even if affected product is no longer in inventory, to the email [email protected]. 3. Upon receiving your Business Response Form to the email, [email protected], a shipping label will be provided to return any recalled product on-hand. 4. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Jordan Anderson at (269) 800-1347 or [email protected] with questions or concerns."

    Distribution

    Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.

    Quantity

    464 units