BEUDAMED
    FDA Enforcement Class II Terminated

    Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.

    Recall: Z-1287-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1287-2015
    Event ID
    70664
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Materialise N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 25, 2015
    Initiation Date
    February 4, 2015
    Classification Date
    March 17, 2015
    Termination Date
    October 30, 2015
    Address
    15 Technologielaan, Heverlee, N/A, Belgium

    Description

    Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.

    Reason

    Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.

    Code Info

    Lot# 124471

    Distribution

    Worldwide Distribution to the Netherlands only.

    Quantity

    1 unit