BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1079-2019 · Initiated January 4, 2019

    Recall

    Recall Number
    Z-1079-2019
    Event Number
    82101
    Firm
    Conformis, Inc.
    FEI Number
    3009844603
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 4, 2019
    Terminated
    June 29, 2020
    Address
    600 Technology Park Dr, Billerica, MA, 01821-4154

    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.

    Action

    Emails were sent to the customers on 1/4/19 requesting return of the affected products.

    Distribution

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

    Quantity

    2