BEUDAMED
    FDA Recall Terminated

    iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

    Recall: Z-1628-2020 · Initiated February 3, 2020

    Recall

    Recall Number
    Z-1628-2020
    Event Number
    85108
    Firm
    Conformis, Inc.
    FEI Number
    3009844603
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    February 3, 2020
    Terminated
    December 2, 2020
    Address
    600 Technology Park Dr, Billerica, MA, 01821-4154

    Description

    iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

    Reason

    A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

    Action

    Conformis Customer Service called three affected customers on February 4, 2020, to ask them to verify tibial tray serial numbers, and confirmed that the three kits in question had the incorrect tibial tray. These affected customers were asked to return the affected product to the firm. Following this action, Conformis Sales Representatives were instructed to verify that all products within their control, including those already placed in hospitals, that were manufactured between September 1, 2019, and February 3, 2020, had tibial tray serial numbers that matched the patient's serial number. No additional affected product was found in the field.

    Distribution

    US Nationwide distribution in the states of LA, NY, TN.

    Quantity

    2