BEUDAMED
    FDA Recall Open, Classified

    TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

    Recall: Z-0488-2026 · Initiated October 13, 2025

    Recall

    Recall Number
    Z-0488-2026
    Event Number
    97703
    Firm
    TMJ Solutions Inc
    FEI Number
    3001237463
    Product Code
    LZD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 13, 2025
    Posted
    November 14, 2025
    Address
    6059 King Dr, Ventura, CA, 93003-7607

    Description

    TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

    Reason

    Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

    Action

    On February 25, 2026 Stryker (TMJ Solutions) issued a " Urgent: Medical Device Recall" Expansion notification to additional, affected consignees. Initial notification and previous expansion was issued on September 30, 2025 and December 4, 2025. TMJ Solutions asked consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product (Attachment B). Segregate the affected products, quarantine and discontinue use. 3. Please complete the Business Reply Form or use the QR Code on Attachment A. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility .

    Distribution

    US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,

    Quantity

    63 units