BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1941-2016 · Initiated May 3, 2016

    Recall

    Recall Number
    Z-1941-2016
    Event Number
    74213
    Firm
    Materialise USA LLC
    FEI Number
    3005718816
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 3, 2016
    Terminated
    June 28, 2016
    Address
    44650 Helm Ct, Plymouth, MI, 48170-6061

    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.

    Action

    Materialise sent an URGENT: Signature Personalized Patient Care System Knee Guides Notification dated May 3, 2016. It was sent to the affected customer via email with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Contact Materialise customer service for additional information or to find a status of the second patient specific surgical guide Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.734-259-7016

    Distribution

    One consignee, Indiana.

    Quantity

    1