BEUDAMED
    FDA Enforcement Class II Terminated

    iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.

    Recall: Z-0475-2021 · Reported December 2, 2020

    Enforcement

    Recall Number
    Z-0475-2021
    Event ID
    86615
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    December 2, 2020
    Initiation Date
    September 21, 2020
    Classification Date
    November 20, 2020
    Termination Date
    June 12, 2023
    Address
    600 Technology Park Dr, N/A, Billerica, MA, 01821-4154, United States

    Description

    iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.

    Reason

    Incorrect hip components were provided in kits.

    Code Info

    Serial numbers 0469255, 0469255

    Distribution

    US Distribution in CA.

    Quantity

    2