BEUDAMED
    FDA Recall Open, Classified

    Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.

    Recall: Z-3264-2024 · Initiated July 24, 2024

    Recall

    Recall Number
    Z-3264-2024
    Event Number
    95139
    Firm
    TMJ Solutions Inc
    FEI Number
    3001237463
    Product Code
    LZD
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 24, 2024
    Posted
    September 26, 2024
    Address
    6059 King Dr, Ventura, CA, 93003-7607

    Description

    Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.

    Reason

    Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO

    Action

    On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device.

    Distribution

    US Nationwide distribution in the state of MN.

    Quantity

    1