BEUDAMED
    FDA Recall Open, Classified

    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    Recall: Z-1234-2023 · Initiated December 6, 2022

    Recall

    Recall Number
    Z-1234-2023
    Event Number
    91479
    Firm
    Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany
    FEI Number
    3002821504
    Product Code
    LZD
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    December 6, 2022
    Posted
    March 8, 2023

    Description

    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    Reason

    Device was shipped without having regulatory approval.

    Action

    Stryker sent an Urgent Medical Device Recall letter dated December 21, 2022, to affected customers. The letter identified the affected product, problem and actions to be taken. This event is isolated to a single patient-specific product that at the time of recall notification, has already been retrieved by the recalling firm. F questions or concerns, contact Customer Service +1 800 962-6558. Please confirm the acknowledgement of this notification to [email protected].

    Distribution

    Distribution of one unit only to a single customer in MA (USA)

    Quantity

    1 unit