BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0731-2019 · Reported January 23, 2019

    Enforcement

    Recall Number
    Z-0731-2019
    Event ID
    81723
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 23, 2019
    Initiation Date
    October 16, 2018
    Classification Date
    January 11, 2019
    Termination Date
    June 29, 2020
    Address
    600 Technology Park Dr, Billerica, MA, 01821-4154, United States

    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.

    Code Info

    Serial Number 0424647

    Distribution

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

    Quantity

    1