BEUDAMED
    FDA Recall Open, Classified

    GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

    Recall: Z-1395-2023 · Initiated April 4, 2023

    Recall

    Recall Number
    Z-1395-2023
    Event Number
    92051
    Firm
    GRAMERCY EXTREMITY ORTHOPEDICS
    FEI Number
    3012478585
    Product Code
    HRS
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    April 4, 2023
    Posted
    April 17, 2023
    Address
    1239 N Glenville Dr, Richardson, TX, 75081-2412

    Description

    GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

    Reason

    Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.

    Action

    On 4/4/23, recall notices were mailed to customers and distributors who were asked to do the following: 1) Quarantine affected kits so they are ready for removal by the firm s sales reps or other contact. 2) If devices were transferred or further distributed, notify customers, or provide a customer list, so the recalling firm can notify these customers directly. 3) Complete and return the response form to [email protected] Customers with questions can contact the firm at 855-436-2278, 9AM 5PM, Monday - Friday.

    Distribution

    US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.

    Quantity

    24