BEUDAMED
    FDA Enforcement Class II Completed

    MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01

    Recall: Z-2213-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2213-2023
    Event ID
    92621
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Materialise N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 26, 2023
    Initiation Date
    April 26, 2023
    Classification Date
    July 20, 2023
    Address
    Technologielaan 15, N/A, Heverlee, N/A, N/A, Belgium

    Description

    MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01

    Reason

    The wrong tibia guide was included intended for a different patient case.

    Code Info

    UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA

    Distribution

    International Distribution to countries of: Germany, Netherlands

    Quantity

    2 Guides