BEUDAMED
    FDA Enforcement Class II Ongoing

    Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

    Recall: Z-0843-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0843-2024
    Event ID
    93729
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    FX SHOULDER
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 7, 2024
    Initiation Date
    August 8, 2023
    Classification Date
    January 29, 2024
    Address
    13465 Midway Rd Ste 310, Dallas, TX, 75244-5183, United States

    Description

    Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

    Reason

    Centered glenosphere box may contain an eccentric glenosphere.

    Code Info

    UDI-DI: 03701037309551, Lot: U0191

    Distribution

    US Nationwide distribution in the state of NJ.

    Quantity

    4