BEUDAMED
    FDA Recall 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 · Initiated February 4, 2015

    Recall

    Recall Number
    Z-1287-2015
    Event Number
    70664
    Firm
    Materialise N.V. 15 Technologielaan Heverlee Belgium
    FEI Number
    3003998208
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 4, 2015
    Posted
    March 17, 2015
    Terminated
    October 30, 2015

    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.

    Action

    Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611.

    Distribution

    Worldwide Distribution to the Netherlands only.

    Quantity

    1 unit