BEUDAMED
    FDA Enforcement Class II Terminated

    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

    Recall: Z-2849-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2849-2020
    Event ID
    86174
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 2, 2020
    Initiation Date
    July 20, 2020
    Classification Date
    August 22, 2020
    Termination Date
    June 21, 2021
    Address
    600 Technology Park Dr, N/A, Billerica, MA, 01821-4154, United States

    Description

    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

    Reason

    Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

    Code Info

    Serial Number: 0469247 Exp. 2021-01-31

    Distribution

    NV

    Quantity

    1 kit