BEUDAMED
    FDA Recall Open, Classified

    TMJ Bilateral Implants, REF: CHG020

    Recall: Z-2524-2026 · Initiated February 11, 2026

    Recall

    Recall Number
    Z-2524-2026
    Event Number
    98509
    Firm
    TMJ Solutions Inc
    FEI Number
    3001237463
    Product Code
    LZD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 11, 2026
    Posted
    June 22, 2026
    Address
    6059 King Dr, Ventura, CA, 93003-7607

    Description

    TMJ Bilateral Implants, REF: CHG020

    Reason

    Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

    Action

    On 2/11/2026, the customer was contacted and verbally informed of the recall. On 4/23/2026, a recall notice was sent to the customer asking them to take the following action: 1) Inform all appropriate members of your organization who need to be made aware of this action. 2) The affected product is already implanted. Following explantation, during revision surgery, the explanted device shall be returned to the firm's sales representative. 3) Complete and return the Business Reply Form (BRF) via email to [email protected] Please contact the firm's quality department [email protected] with questions or concerns.

    Distribution

    US Nationwide distribution in the state of MA.

    Quantity

    1