BEUDAMED
    FDA Enforcement Class II Terminated

    Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.

    Recall: Z-1941-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1941-2016
    Event ID
    74213
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Materialise USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 15, 2016
    Initiation Date
    May 3, 2016
    Classification Date
    June 9, 2016
    Termination Date
    June 28, 2016
    Address
    44650 Helm Ct, N/A, Plymouth, MI, 48170-6061, United States

    Description

    Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.

    Reason

    A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.

    Code Info

    Lot #154970

    Distribution

    One consignee, Indiana.

    Quantity

    1