BEUDAMED
    FDA Recall Terminated

    iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

    Recall: Z-0731-2019 · Initiated October 16, 2018

    Recall

    Recall Number
    Z-0731-2019
    Event Number
    81723
    Firm
    Conformis, Inc.
    FEI Number
    3009844603
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 16, 2018
    Terminated
    June 29, 2020
    Address
    600 Technology Park Dr, Billerica, MA, 01821-4154

    Description

    iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

    Reason

    The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.

    Action

    The customer was contacted via email on 10/16/18.

    Distribution

    The products were distributed to the following US states: TN.

    Quantity

    1