BEUDAMED
    FDA Enforcement Class II Terminated

    iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

    Recall: Z-1079-2019 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-1079-2019
    Event ID
    82101
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 10, 2019
    Initiation Date
    January 4, 2019
    Classification Date
    March 30, 2019
    Termination Date
    June 29, 2020
    Address
    600 Technology Park Dr, N/A, Billerica, MA, 01821-4154, United States

    Description

    iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

    Reason

    The labeling of the boxes and sterile pouches did not match the contents.

    Code Info

    Serial Numbers 0434436 and 0434836

    Distribution

    The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany

    Quantity

    2