BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated July 18, 2025

    Recall

    Recall Number
    Z-2548-2025
    Event Number
    97412
    FEI Number
    1000116912
    Product Code
    KWS
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 18, 2025
    Posted
    September 10, 2025
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445

    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.

    Action

    On July 29, 2025, Enovis issued a "Urgent Medical Device Recall Notification via Email to affected consignees. On August 4, 2025, Enovis issued an update to the recall notification via E-Mail requesting consignees rework affected trays and returned affected products. Enovis asked consignees to take the following actions: 1. Continue using the wedge reamer assembly while carefully inspecting and following the specific details in the supplied Quality Bulletin. 2. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3. Please see the attached quality Bulletin 4. By 9/13/25, the firm will reach out regarding reworking and returning trays. 5. Acknowledge receipt of notification.

    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