BEUDAMED
    FDA Enforcement Class II Ongoing

    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

    Recall: Z-1133-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-1133-2023
    Event ID
    91376
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2023
    Initiation Date
    November 14, 2022
    Classification Date
    February 13, 2023
    Address
    600 Technology Park Dr Ste 3, N/A, Billerica, MA, 01821-4154, United States

    Description

    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

    Reason

    Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.

    Code Info

    UDI-DI 00810933030582 Lot D221301

    Distribution

    US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA, MA, MD, MS, NE, NH, NV, NY, OH, TN, WI, WY.

    Quantity

    70