BEUDAMED
    FDA Enforcement Class II Terminated

    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.

    Recall: Z-0162-2016 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0162-2016
    Event ID
    72425
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Materialise N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 4, 2015
    Initiation Date
    September 23, 2015
    Classification Date
    October 23, 2015
    Termination Date
    February 12, 2016
    Address
    15 Technologielaan, N/A, Heverlee, N/A, N/A, Belgium

    Description

    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.

    Reason

    Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.

    Code Info

    42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03

    Distribution

    Distributed in MI, ID, TX, and in France.

    Quantity

    4