BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1395-2023 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1395-2023
    Event ID
    92051
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GRAMERCY EXTREMITY ORTHOPEDICS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2023
    Initiation Date
    April 4, 2023
    Classification Date
    April 17, 2023
    Address
    1239 N Glenville Dr, N/A, Richardson, TX, 75081-2412, United States

    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.

    Code Info

    UDI-DI B471701200010, Serial Number(Expiration Date): 1022000493(10/13/27), 1022000623(10/13/27), 1022000683(10/13/27), 1022000243(10/13/27, 1022000313(10/13/27), 1022000913(10/13/27), 1022001213(10/13/27), 1022000403(10/13/27), 1022000383(10/13/27), 1022000883(10/13/27), 1022000353(10/13/27), 1022000663(10/13/27), 1022000733(10/13/27), 1022000793(10/13/27), 1022000983(10/13/27), 1022000993(10/13/27), 1022000373(10/13/27), 1022001193(10/13/27), 1022000523(10/13/27), 1022000283(10/13/27), 1022000223(10/13/27), 1022000363(10/13/27), 1022000413(10/13/27), 1022000453(10/13/27)

    Distribution

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

    Quantity

    24