BEUDAMED
    FDA Recall Open, Classified

    TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

    Recall: Z-2308-2026 · Initiated April 3, 2026

    Recall

    Recall Number
    Z-2308-2026
    Event Number
    98773
    Firm
    Grace Medical, Inc.
    FEI Number
    1000022662
    Product Code
    ETB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 3, 2026
    Posted
    June 4, 2026
    Address
    8500 Wolf Lake Dr, Ste 110, Bartlett, TN, 38133-4104

    Description

    TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

    Reason

    Due to incorrect functional length on device labeling.

    Action

    On 04/03/2026, the firm emailed a "RECALL NOTICE" to it single customer informing them that the firm determined the pistons were manufactured with an incorrect functional length. Devices are labeled as 3.75 mm but have an actual functional length of 4.00 mm. The customer was instructed to: " Immediately discontinue use and quarantine affected product " Return affected product using the provided RMA " If any devices have been used, provide the date(s) of surgery on the response form " Complete and return the enclosed Recall Response Form For questions - contact Grace Medical at 901-386-0990 or [email protected].

    Distribution

    U.S Nationwide distribution in the state of MD.

    Quantity

    7