BEUDAMED
    FDA Recall Completed

    iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

    Recall: Z-0899-2022 · Initiated February 22, 2022

    Recall

    Recall Number
    Z-0899-2022
    Event Number
    89903
    Firm
    Conformis, Inc.
    FEI Number
    3009844603
    Product Code
    JWH
    Status
    Completed
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 22, 2022
    Address
    600 Technology Park Dr, Ste 3, Billerica, MA, 01821-4154

    Description

    iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

    Reason

    Incorrect tibial base plate implant packaged in kit

    Action

    Conformis issued Notifications to Conformis sales representative via phone conversation. The sales representative spoke with the respective surgeons on 2/22/22 to retrieve the product. No phone script was saved.

    Distribution

    MS

    Quantity

    1 unit