BEUDAMED
    FDA Recall 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 · Initiated July 20, 2020

    Recall

    Recall Number
    Z-2849-2020
    Event Number
    86174
    Firm
    Conformis, Inc.
    FEI Number
    3009844603
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 20, 2020
    Terminated
    June 21, 2021
    Address
    600 Technology Park Dr, Billerica, MA, 01821-4154

    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

    Action

    Conformis notification to field sales representative on July 20,2020 to remove product from use.

    Distribution

    NV

    Quantity

    1 kit