BEUDAMED
    FDA Enforcement Class II Ongoing

    RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.

    Recall: Z-0532-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0532-2024
    Event ID
    93428
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2023
    Initiation Date
    September 6, 2023
    Classification Date
    December 12, 2023
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.

    Reason

    Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver

    Code Info

    Part Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893

    Distribution

    U.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX, VA, and WA O.U.S.: None

    Quantity

    146 units