BEUDAMED
    FDA Recall Open, Classified

    BEAR Implant. Model Number: 1000.

    Recall: Z-1220-2026 · Initiated December 31, 2025

    Recall

    Recall Number
    Z-1220-2026
    Event Number
    98280
    Firm
    Miach Orthopaedics
    FEI Number
    3020652309
    Product Code
    QNI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 31, 2025
    Posted
    January 29, 2026
    Address
    69 Milk St, Ste 100, Westborough, MA, 01581-1224

    Description

    BEAR Implant. Model Number: 1000.

    Reason

    Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.

    Action

    Notification to Sales Representatives and consignees began on about 12/31/2025 via email and letter titled URGENT MEDICAL DEVICE RECALL NOTIFICATION. Consignees were instructed to identify and quarantine all unused inventory of the affected lot, discontinue distribution of the affected lot, return all unused affected product, and complete and return the provided Recall Acknowledgement Form. Additionally, consignees were requested to notify customers if the affected lot was further distributed.

    Distribution

    US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI.

    Quantity

    284 units