BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

    Recall: Z-0418-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0418-2015
    Event ID
    69632
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Materialise USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 3, 2014
    Initiation Date
    October 16, 2014
    Classification Date
    November 21, 2014
    Termination Date
    February 17, 2015
    Address
    44650 Helm Ct, N/A, Plymouth, MI, 48170-6061, United States

    Description

    Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

    Reason

    The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.

    Code Info

    00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902

    Distribution

    Nationwide Distribution to MN only

    Quantity

    1