BEUDAMED
    FDA Recall Terminated

    iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

    Recall: Z-0063-2020 · Initiated August 22, 2019

    Recall

    Recall Number
    Z-0063-2020
    Event Number
    83760
    Firm
    Conformis, Inc.
    FEI Number
    3009844603
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 22, 2019
    Terminated
    July 8, 2020
    Address
    600 Technology Park Dr, Billerica, MA, 01821-4154

    Description

    iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

    Reason

    Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.

    Action

    Conformis was notified of the issue on 8/22/19 when a customer reported that there had been a package mix-up. Conformis immediately contacted the customer associated with the other serial number involved in the mix-up and requested the return of that stem. Conformis is not aware of any other instances of mixed product.

    Distribution

    Distributed to consignees in MD and NV.

    Quantity

    1