BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile

    Recall: Z-2548-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2548-2025
    Event ID
    97412
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 17, 2025
    Initiation Date
    July 18, 2025
    Classification Date
    September 10, 2025
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile

    Reason

    Their is a potential that the reamer may kick or bind up during or immediately prior to use.

    Code Info

    Lot Code: All Lots GTIN: 00190446843818

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.

    Quantity

    447 units