BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1133-2023 · Initiated November 14, 2022

    Recall

    Recall Number
    Z-1133-2023
    Event Number
    91376
    Firm
    Conformis, Inc.
    FEI Number
    3009844603
    Product Code
    OIY
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 14, 2022
    Posted
    February 13, 2023
    Address
    600 Technology Park Dr, Ste 3, Billerica, MA, 01821-4154

    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.

    Action

    On November 14, 2022, the firm sent an Instrument care reminder to field reps, which included an Instrument handling and care reminder. The firm sent additional letters and emails to affected consignees starting January 17, 2023. Consignees were instructed to inspect their inventory for product from the affected lot. Immediately cease use of affected product and contact customer service if a field representative has not already reached out to you. Conformis will have a field representative come onsite to inspect, apply Loctite, and review techniques for inspecting the instrument. Customers were informed they may continue to use impactor handles from other lots. However, they should ensure they are properly connecting the impactor handle to the keel punch (Refer to surgical technique guide).

    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