BEUDAMED
    FDA Enforcement Class II Terminated

    iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

    Recall: Z-0064-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0064-2020
    Event ID
    83760
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    October 16, 2019
    Initiation Date
    August 22, 2019
    Classification Date
    October 8, 2019
    Termination Date
    July 8, 2020
    Address
    600 Technology Park Dr, N/A, Billerica, MA, 01821-4154, United States

    Description

    iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

    Reason

    Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.

    Code Info

    0447621

    Distribution

    Distributed to consignees in MD and NV.

    Quantity

    1