BEUDAMED
    FDA Recall Open, Classified

    BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

    Recall: Z-0479-2026 · Initiated February 2, 2023

    Recall

    Recall Number
    Z-0479-2026
    Event Number
    97742
    Firm
    Miach Orthopaedics
    FEI Number
    3020652309
    Product Code
    QNI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 2, 2023
    Posted
    November 7, 2025
    Address
    69 Milk St, Ste 100, Westborough, MA, 01581-1224

    Description

    BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

    Reason

    The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

    Action

    On January 30, 2023 RE: BEAR Implant Hydration memo emails were sent to sales staff. If you observe an implant that hydrates too quickly (e.g., less than 30 seconds) and appears that it may not remain intact upon insertion into the knee, do not attempt to implant the device. We would recommend you always have a backup device available to address such circumstances. We plan to revise the Tips and Pearls document, ML-1027, to provide further instructions/details on how to properly hydrate the BEAR device. In the meantime, one way to avoid shortened hydration time is to consider hydrating the dense side of the implant first and continue toward the porous side . To date, all reports of this observation have involved Lot # 7008409. As a precaution and to ensure customer satisfaction, we are asking that you return all devices from this lot that are currently in your trunk stock (in your possession). Chris Brown will work with you to coordinate returns as well as replacing these trunk stock devices. Please contact me ([email protected]) or Arjun ([email protected]) if you have questions.

    Distribution

    US Nationwide distribution.

    Quantity

    167 units