BEUDAMED
    FDA Enforcement Class II Completed

    iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

    Recall: Z-0899-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0899-2022
    Event ID
    89903
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    April 20, 2022
    Initiation Date
    February 22, 2022
    Classification Date
    April 8, 2022
    Address
    600 Technology Park Dr Ste 3, N/A, Billerica, MA, 01821-4154, United States

    Description

    iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

    Reason

    Incorrect tibial base plate implant packaged in kit

    Code Info

    Serial Number: 0496242 UDI: M572TPS3011113011

    Distribution

    MS

    Quantity

    1 unit